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covid-19 (66)

Gold Level Contributor

Eli Lilly's antibody combo posted impressive new data.

Eli Lilly’s COVID-19 antibody combo already boasts an FDA authorization for patients at a high risk of developing severe disease, but now the company has even stronger data backing the duo.

In trial data released Wednesday, the company said its bamlanivimab-etesevimab duo slashed the risk of hospitalization and death by a whopping 87% versus placebo. Investigators tested a combination of 700 mg of bamlanivimab and 1400 mg of etesevimab in a trial comprising 769 patients total.

It's the starkest reduction in hospitalizations and deaths for a COVID-19 therapeutic seen so far, and in a “fairly sizable” sample size, Lilly’s COVID-19 therapeutics platform leader Janelle Sabo said in an interview. 

Lilly's combo previously posted a 70% reduction in hospitalizations and deaths at higher doses of 2800 mg each. The new trial used the doses now authorized by the FDA in newly diagnosed patients at high risk of severe disease—the same population the combo is approved to treat.

The new trial reinforces other data Lilly has seen to date and shows the FDA's authorization covers the right doses in the right patients, Sabo added.  

The combo scored its emergency nod last month on the heels of the earlier data. Lilly has partnered with Amgen to help produce up to 1 million doses of the cocktail this year. 

Patients over 65, or those under 65 but who are overweight or have multiple health problems, qualify as high-risk for treatment with the drug. For patients under 65, it’s “about looking at the combination of weight” and other factors, Sabo said. 

In the new study, investigators tracked four hospitalizations and zero deaths among patients who received the Lilly antibody combo. That compared with 11 hospitalizations and four deaths for patients on placebo. 

In the two phase 3 cohorts so far, zero patients who received the antibody combination have died, while 14 patients died on placebo. Thirteen of those placebo deaths were deemed to be related to COVID-19. 

After its FDA authorization, Lilly inked another supply deal with the U.S. government covering 100,000 doses for $210 million. The doses will be delivered before the end of the month, and the government has the option to purchase 1.1 million more doses through Nov. 25 depending on demand. 

While monoclonal antibodies have been available for months, initial uptake lagged expectations. Early data showed that only 1 in 20 eligible patients were getting an antibody therapeutic, Sabo said, but that has been improving to around 1 in 7.  

“We still can do better,” Sabo said. “We have an obligation to continue to create awareness of therapeutics" alongside the national vaccine push that's underway.

Originally published by
Eric Sagnowsky | March 10, 2021
Fierce Pharma

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Gold Level Contributor

Photo: Spencer Platt/Getty Images

Healthcare organizations can harness machine learning to schedule vaccines, streamline patient communications and even prioritize access – but the technology is hardly infallible.

The question of who should get access to COVID-19 vaccines first has varied from state to state, with some governments prioritizing those with high-risk conditions and others lowering the age of eligibility. 

One South Dakota-based system, Sanford Health, is using a machine learning model to identify which individuals are at greatest risk of having severe COVID-19 outcomes – and applying the algorithm to eligible groups.  

"With [those] 85,000 people what we can do is take a real-time picture that evolves over time, using computer learning to tell us what patients or what people in the Midwest get the sickest from COVID-19," said Sanford chief physician Dr. Jeremy Cauwels to Minnesota Public Radio.

Cauwels told MPR that he believes an artificial intelligence approach is more equitable than random choice for administering the vaccine. 

Sanford isn't alone. Experts say AI has big potential to assist with the COVID-19 vaccine rollout.  

"The pace and scale of the vaccine rollout is unprecedented, and we are seeing AI play a role," said Lori Jones, chief revenue officer and president for the provider market at Olive, an AI-as-a-service vendor.  

Rather than using AI to identify at-risk patients, Jones noted its potential to promote efficiency within existing workflows.

"The biggest areas of focus for organizations that we’re working with have all related to managing the organization, scheduling, preregistration and communications activity around the testing and vaccines themselves, with additional automation activity to streamline patient communications and drive better vaccine efficacy by ensuring patients are aware, prepared and present to receive second doses," Jones explained.  

"We’ve got an important mission ahead of us still, and if we can’t expand the capacity of organizations delivering the vaccines to take on more patients faster, then there is a very real risk that this process could take years, not months," she said.  

Jones pointed to chatbots as a prime example of the way AI can be used in conjunction with other tools, specifically when it comes to patient engagement.  

"AI-enabled digital call centers are helping organizations manage the significant level of interest in key vaccine information," she said. "FAQs can be converted into chatbots to refresh the available information to be COVID-19-specific."

"If the healthcare industry continues to rely on paper forms, phone calls, mobile apps, portals and email campaigns, process bottlenecks will create long lines, confusion and frustration," agreed Greg Johnsen, CEO of LifeLink, which powers conversational solutions for healthcare organizations.   

"Additional complexities around new documentation, specific follow-up vaccination windows and an influx of people that are new patients could overwhelm current intake and scheduling processes," said Johnsen. "Building a handful of digital assistants versus training thousands of individuals is also a key consideration when it comes to efficiency and cost."   

That said, there are unmistakable downsides to relying on AI – namely, expecting the technology to be infallible.   

"Pursuing AI strategies can certainly bring about adoption challenges, and adoption is critical to any AI strategy," said Jones. "One roadblock to AI adoption is understanding that AI tools aren’t replacing human healthcare workers: They’re actually empowering them and helping them work better, faster."  

There are also the ever-present dangers of reproducing bias or using faulty algorithms. In December of this past year, Stanford Medical Center came under fire for prioritizing administrators over frontline health workers due to an error in the rule-based formula it was using to help calculate who would get vaccinated first.

Sanford, in South Dakota, is not using race or ethnicity as a factor in its algorithms, theorizing that individuals with higher rates of chronic disease will be elevated in the prioritization.   

But given the disproportionate effect of COVID-19 on patients of color – especially Black, Latinx and Native people – other health systems in nearby states say it's important to take those demographics into consideration.  

The University of Wisconsin-Madison did use a race-based algorithm to prioritize employee vaccines in its initial distribution, Shiva Bidar-Sielaff, chief diversity officer at UW Health, told MPR. 

"It's incredibly important to realize that all data points to the fact that, unfortunately, race and ethnicity have been shown to create a much higher risk of hospitalization and death for COVID-19," said Bidar-Sielaff.   

"So when we looked at our algorithm, we saw that if you add age and SVI, which has that component of race and ethnicity, it's a multiplier effect in how much higher risk an individual is at for hospitalization and death," she said.

Some companies are stressing the need for caution when it comes to using AI for vaccine allocation. 

Representatives from Salesforce, which launched its Vaccine Cloud tool this past month to assist clients with managing vaccine administration, said they were working to ensure equitable distribution.  

"Vaccine Cloud can deliver integrated and customized solutions for our customers, including the ability to use data and insights to support [the] distribution, management and administration of vaccines," a Salesforce spokesperson told Healthcare IT News via email.  

"However, our Principles for the Ethical Use of COVID-19 Vaccine Technology Solutions explicitly state that AI should not be used to predict personal characteristics or beliefs that would affect a person’s or group’s prioritization for access to vaccines, and we work closely with our partners and teams on this guidance."  

Still, it's clear that AI – when deployed responsibly – may be able to make the COVID-19 vaccine rollout faster and more effective for at-risk patients.

"The vaccine rollout is the ultimate test for AI to showcase the breadth of time-saving and efficacy capabilities, and demonstrate its full value for healthcare leaders," said Jones. "When organizations emerge from the COVID crisis, we see AI becoming an integral part of their digital strategy."

Originally published by
Kat Jercich | February 11, 2021
Healthcare IT News

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Gold Level Contributor

The full clearance follows up on an emergency authorization granted by the FDA last summer, aimed at the COVID-19 pandemic. (Getty/sudok)

The FDA has cleared an artificial intelligence program designed to predict which patients in an intensive care unit will begin to deteriorate, giving clinicians up to eight hours of advanced warning and time to prepare.

Developed by CLEW, the system gathers data from electronic health records, vital sign monitors and connected ICU devices, and uses machine learning models to calculate each person’s risk of their heart and blood flow becoming unstable.

The full clearance follows up on an emergency authorization granted by the agency last year, aimed at the COVID-19 pandemic, with a focus on spotting the early signs of respiratory distress.

The CLEWICU system also identifies patients at a low risk of decompensating in near real-time, allowing staff to better prioritize the use of their resources.

"We are proud to have received this landmark FDA clearance and deliver a first-of-its-kind product for the industry, giving healthcare providers the critical data that they need to prevent life-threatening situations," CLEW CEO Gal Salomon said in a statement.

Previous studies by CLEW showed the system was able to provide accurate alerts to staff by a median of three-and-a-half hours early. The company also plans to develop AI models predicting patient deterioration across all care settings.

Originally published by
Conor Hale | February 8, 2021
FierceBiotech

 

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Bronze Level Contributor

4 key trends for medtech in 2021

Image: Adeline Kon/MedTech Dive

COVID-19 challenges, and opportunities, will continue to impact companies this year.

The calendar signals a new year but the medtech industry in 2021 will feel the lingering effects, both positive and negative, from the global coronavirus pandemic. 

With the resurgence of the virus and emergence of new more contagious strains, COVID-19 will have major impacts on companies as much as 2020, albeit with the benefit of insights gleaned from the historic year and its unprecedented business environment.     

Earlier this month, medtech and diagnostics companies gathered virtually to discuss 2021 prospects at J.P. Morgan's annual healthcare conference. Executives painted a mixed picture with the first half of the year looking bumpier than the second half.

Not surprisingly, many companies are not providing 2021 guidance due to the uncertainty caused by COVID-19. However, Craig-Hallum analyst Alex Nowak noted recently that most of the companies his firm covers have spoken optimistically about a full recovery taking hold in 2021.

"The recovery though will not be outsized year/year growth in 1Q21-3Q21, but instead consistent levels of quarter/quarter gains throughout the year," Nowak wrote in a research note.    

Below are four big trends to watch in 2021 for the industry.

Elective procedures remain under pressure

Wall Street expects declines in elective care in the near term to continue as coronavirus cases keep rising. While the rollout of vaccines will likely help volumes, procedure comebacks are not expected until the second half of 2021, according to J.P. Morgan analysts.

To be sure, there will be winners and losers financially in this scenario.

"The ones affected were, to no surprise, those tied to elective procedures or were hospital-oriented," according to Nowak. "The real weakness was procedures that were not entirely critical (or critical and could be shifted outside the hospital), nor driven by higher income, such as spine surgery."

While Moody's expects procedure volumes will continue to recover in 2021 as patients who deferred procedures to treat chronic illnesses return to their healthcare providers, the investor service predicts demand will be volatile based on the spread of COVID-19.

Moody's expects transcatheter aortic valves, a key revenue driver, "will return to double-digit growth" for leaders such as Edwards Lifesciences and Medtronic.

Edwards on Wednesday reported that U.S. TAVR sales were actually down lower than Wall Street's expectations in the fourth quarter, and recent procedure slowdowns are expected to spill into 2021. However, CEO Michael Mussallem believes that the company will still hit its guidance of growing TAVR globally by 15-20% this year.

Medtronic warned earlier this month that due to the COVID-19 surge the company now expects overall business to be "roughly flat" this quarter, on an organic basis, instead of flat to slightly up. 

CEO Geoff Martha noted that Medtronic didn’t see much of a negative impact from the surge in coronavirus cases in October, November and even the first half of December. However, the medtech giant started to see "some impact" starting over the holidays. 

Nonetheless, Martha called hospitals more experienced at handling the current COVID-19 surge while maintaining capacity for non-coronavirus patients. He cited pockets in the U.S. and Europe "where it has slowed down a bit" in recent weeks.  

"It is more of an elective case pullback issue versus some other issue that's unique to Medtronic," Martha said. "Based on the feedback that we're getting from hospitals, we remain optimistic that this is going to be short lived."   

However, executives from Baxter and Boston Scientific appear to be more concerned about the ability of some hospitals to manage the coronavirus stresses on their health systems as the number of cases continue to rise.  

Baxter CFO Jay Saccaro at the recent J.P. Morgan conference described the current coronavirus surge as "volatile" and that Baxter will be taking "as much time as we possibly can to put together guidance." 

Boston Scientific expects a rebound in procedure volumes this year. However, the company is not providing 2021 guidance at this time. CEO Mike Mahoney told analysts that he expects “some COVID impact” and “softness” in the first quarter “given the market environment.” However, Mahoney said with the increasing rollout of COVID-19 vaccines in 2021 the situation will “improve each month.”    

Another banner year for COVID-19 testing

Demand for COVID-19 testing will continue to accelerate over the next year, with volumes remaining high until vaccines are widely distributed, according to Moody's.

"This will benefit companies that sell diagnostic tests, like Abbott Laboratories and Becton Dickinson, as well as life science companies that provide reagents used in these tests like Thermo Fisher Scientific," Moody's analysts wrote in their 2021 outlook for the global healthcare sector. 

Despite the rollout of coronavirus vaccines, Abbott, Hologic and Quidel are ramping up their manufacturing capabilities in anticipation of another banner year for COVID-19 testing. CEOs from the diagnostic makers laid out their coronavirus test plans earlier this month at J.P. Morgan. 

Hologic CEO Stephen MacMillan said the company has more than doubled its molecular diagnostic manufacturing capacity and is investing to more than triple capacity from 25 million tests in the fourth quarter of 2020 to 75 million tests per quarter by the second quarter of 2022. 

"Everybody thought as soon as vaccines came, testing is going to go away. I think everybody is now seeing the realities of rolling out vaccines, of distribution chains. There is so much more complexity," MacMillan said. "This market, we believe, continues to grow and continues to be strong. And while it will certainly come down at some point, we believe it's going to be stronger for longer."  

Abbott CEO Robert Ford said he expects high demand and volume for tests throughout 2021. The company is near completion of capacity expansion at U.S. manufacturing sites, which Ford estimated will enable production of tens of million more of its BinaxNOW COVID-19 antigen tests per month for sale to schools, workplaces, and pharmacies.

Quidel's QuickVue SARS test, a pregnancy test-style antigen diagnostic that like Abbott's BinaxNOW delivers results in minutes, is the focus of an at-home coronavirus testing effort.   

"We are now anticipating a QuickVue SARS OTC at-home approval, which would not require a prescription," CEO Doug Bryant said at the conference. "We think it's the future of the company."  

Early in 2021, Quidel hopes to have QuickVue tests available as OTC at home productsThe company plans to manufacture as many of the diagnostics that it can this year.  

Tuck-in acquisitions poised to take off

While M&A slowed last year due to the coronavirus pandemic, a report from consultancy EY predicts medtech dealmaking to jump in 2021 as companies are armed with a record high of roughly $500 billion in financial firepower. So far this year, the industry has seen a flurry of activity.

Hologic kicked the trend off in January with an acquisition of Somatex Medical for $64 million, and less than a week into 2021 added its second tuck-in with the acquisition of Biotheranostics for $230 million. PerkinElmer struck a deal to buy tuberculosis test provider Oxford Immunotec for $591 million and Thermo Fisher Scientific announced it will acquire privately-held molecular diagnostic maker Mesa Biotech for $450 million in cash.

The biggest deal over the first weeks of January was Steris' purchase of Cantel Medical in a cash and stock acquisition of approximately $4.6 billion, followed by Boston Scientific's announcement that it will purchase cardiac monitoring company Preventice Solutions in a $925 million deal and Philips' plans to acquire Capsule Technologies for a cash consideration of $635 million.   

At Boston Scientific, strategic tuck-ins remain the company’s “number one priority” when it comes to capital deployment with a focus on high-growth adjacent markets, CEO Mike Mahoney said earlier this month, noting $1.9 billion in cash on hand as of the end of last year. He also said the company will continue to be active with its venture capital portfolio “which has historically served as well as a nice pipeline” for M&A.     

Medtronic's Martha said that the medtech giant plans to continue to look for M&A opportunities in 2021 after the company last year accelerated its momentum for tuck-in acquisitions, announcing seven such deals with a combined total consideration of over $1.6 billion. 

Baxter CEO Joe Almeida said the company continues to "think very seriously" and to "evaluate" M&A this year. "I'm not in a position to tell you affirmatively that 2021 is the year of M&A," he remarked, though it is part of the medtech's playbook.

While some companies will look for tuck-in acquisitions, a handful of deals over $1 billion should be expected, according to John Babbitt, EY's MedTech leader for the Americas. In addition, EY sees several subsectors as top targets in 2021 for M&A activity including diagnostics, digital health, and remote patient monitoring.  

Digital, remote tech adoption to grow

Last year, the need to create safe physical distances between healthcare workers and COVID-19 patients prompted medtechs to modify how their devices are used, including remote programming and monitoring. This year, executives say they will continue to adopt many of the features, which are becoming permanent offerings.

Martha said Medtronic will be increasingly incorporating the technology across its product portfolio.  

“You are already seeing this with the advances we have made in remote monitoring and remote programming of many of our devices. We have added advanced capabilities to cardiac rhythm devices, diabetes insulin pumps, and ventilators, just to name a few,” Martha said.

Abbott's Ford said his company is continuing to adopt remote care and digital health technologies as a result of the pandemic, which has accelerated the trend. However, Ford made the case at J.P. Morgan that the benefits of such tech goes beyond just COVID-19.

"It allows for much more proactive management. We see that in some of our portfolio. It can decrease the response time, especially if you've got like an urgent care situation. It can really bring that response time down lower, cuts up a lot of the logistical issues, the challenges of in-person, and then ultimately can lead to lower healthcare cost," Ford said.

He pointed to the FDA's approval in July of the Gallant implantable cardioverter defibrillator family of devices to help manage heart rhythm disorders, which offer Bluetooth technology and a new patient smartphone app for improved remote monitoring.   

Boston Scientific in 2021 is also looking to build on “healthcare digital adoption” by accelerating and expanding its remote technology capabilities, according to CEO Mahoney.  

The company has “leveraged COVID” to accelerate its digital investments and capabilities in such focus areas as clinical trials, customer engagement, mobile solutions, medical education and remote case support, Mahoney said. 

Boston Scientific’s initiatives include remote case support and virtual reality solutions, remote monitoring of clinical trials, as well as teleproctoring and virtual medical education.     

“We see these platforms as a key catalyst for growth and structural and cost savings opportunities over time, and continue to expand our footprints and these digital capabilities,” Mahoney added.   

Originally published by
Greg Slabodkin | January 29, 2021
Medtech Dive

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Bronze Level Contributor

The approach promises to be much faster than culturing bacterial samples in a lab, taking about four hours to pick up any of 52 different pathogens. (Getty Images)

Researchers at the University of Cambridge have developed a DNA test to help spot dangerous secondary infections that may develop during COVID-19 treatment—such as cases of pneumonia associated with ventilator equipment provided during intensive care.

Patients under mechanical ventilation are typically given anti-inflammatory drugs to ease damage to their lungs, however this may leave them more susceptible to bacteria and fungi in the hospital.

The test, developed at Cambridge University Hospitals in collaboration with Public Health England, is designed to identify the infection and help suggest the appropriate course of antibiotics. 

The approach—which promises to be much faster than culturing bacterial samples in a lab, taking about four hours total to pick up 52 different pathogens—is currently being rolled out to healthcare providers under the university’s NHS Foundation Trust.

"Early on in the pandemic we noticed that COVID-19 patients appeared to be particularly at risk of developing secondary pneumonia, and started using a rapid diagnostic test that we had developed for just such a situation," said Andrew Conway Morris, of Cambridge's Department of Medicine, who co-authored a paper examining the rates of ventilator-associated pneumonia among COVID-19 patients.

"Using this test, we found that patients with COVID-19 were twice as likely to develop secondary pneumonia as other patients in the same intensive care unit," Morris said. As to the reason why, people with severe infections tend to spend more time on ventilators, and may also have poorly regulated or overactive immune system in the face of the virus.

It also marks one of the first times that high-throughput PCR sequencing has been employed in the university’s routine clinical practice in such a manner.

"We found that although patients with COVID-19 were more likely to develop secondary pneumonia, the bacteria that caused these infections were similar to those in ICU patients without COVID-19," said Cambridge researcher and lead study author Mailis Maes. "This means that standard antibiotic protocols can be applied to COVID-19 patients."

Originally published by
Conor Hale | January 15, 2021
Fierce Biotech

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Bronze Level Contributor

Treating critically ill COVID-19 patients with drugs typically used for arthritis may significantly improve survival, a landmark study has found.

The findings, which have not yet been peer-reviewed, come from the REMAP-CAP trial, which evaluates the effect of treatments on a combination of survival and length of time patients need support in an intensive care unit (ICU).

Initial findings reported in November showed that tocilizumab, a drug used to treat arthritis, was likely to improve outcomes among critically ill COVID-19 patients. But the impact on patient survival and length of time on organ support in ICU was not clear at that time.

"This is a significant finding which could have immediate implications for the sickest patients with COVID-19" Professor Anthony Gordon

Now, the latest analysis shows that tocilizumab and a second drug called sarilumab – both types of immune modulators called IL-6 receptor antagonists – have a significant impact on patient survival, reducing mortality by 8.5%.*

Furthermore, the treatment also improved recovery so that on average patients were able to be discharged from the intensive care unit (ICU) about a week earlier.

The latest analysis is published in a pre-print available on medRxiv, with the findings submitted to a peer-reviewed journal.

“This is a significant finding which could have immediate implications for the sickest patients with COVID-19,” said Professor Anthony Gordon, Chair in Anaesthesia and Critical Care at Imperial College London and a Consultant in Intensive Care Medicine at Imperial College Healthcare NHS Trust.

“We found that among critically ill adult patients – those receiving breathing support in intensive care – treatment with these drugs can improve their chances of survival and recovery,” explained Professor Gordon. “At a time when hospitalisations and deaths from COVID-19 are soaring in the UK, it’s crucial we continue to identify effective treatments which can help to turn the tide against this disease.”

At the end of last year, positive early findings on tocilizumab were released before the full data had been collected. With the full analysis now available, researchers are confident the findings could have immediate clinical implications for patients.

Tocilizumab and sarilumab are immunosuppressive drugs used to treat rheumatoid arthritis. They were two of several immune modulation treatments included in the REMAP-CAP trial.

Patients receiving tocilizumab and sarilumab were more likely to improve (measured by a combination of reduced time on organ support, such as a ventilator, in the ICU and surviving the hospital admission) compared to patients who received no immune modulator.

Full findings

At the time of full analysis 353 patients had been assigned to tocilizumab, 48 to sarilumab and 402 to control. The majority of patients were also treated with corticosteroids and were receiving respiratory support.

The trial data yielded an odds ratio of 1.64 for a better outcome with tocilizumab, and 1.76 for sarilumab, compared to no immune modulation, with a high degree of statistical certainty (>99.5% probability that both treatments are superior to no immune modulation).

Hospital mortality was reported as 27.3% among patients receiving IL-6 receptor agonists (28.0% for tocilizumab, 22.2% for sarilumab) compared with 35.8% for control group.

Professor Gordon added: “Previous trials using IL-6 receptor agonists have showed no clear benefit on either disease progression or survival in COVID-19 patients, but those studies included less severely ill patients and started treatment at different stages in the disease course.

“A crucial difference may be that in our study, critically ill patients were enrolled within 24 hours of starting organ support. This highlights a potential early window for treatment where the sickest patients may gain the most benefit from immune modulation treatment.”

In a Government statement, Deputy Chief Medical Officer Professor Jonathan Van-Tam said: “This is a significant step forward for increasing survival of patients in intensive care with COVID-19. The data shows that tocilizumab, and likely sarilumab, speed up and improve the odds of recovery in intensive care, which is crucial for helping to relieve pressure on intensive care and hospitals and saving lives.

"This is evidence of the UK’s excellent research infrastructure and life sciences industry advancing global understanding of this disease, which we have done both through our own programme of clinical research and through our ability to make very large contributions to international studies.”

REMAP-CAP study is led by Imperial College London and the Intensive Care National Audit & Research Centre (ICNARC) in the UK and University Medical Center Utrecht in Europe. It began investigating treatments for COVID-19 in March 2020, enrolling hospitalised patients with either moderate or severe (requiring ICU care) COVID-19 disease.

The study design randomises patients to multiple combinations of treatments, enabling researchers to evaluate different treatments for COVID-19, including antivirals, drugs which modulate the immune response, and therapies that modulate or support other vital aspects of the body's response to the virus.

In total, over 3,900 patients in 15 countries have been enrolled at more than 290 hospitals worldwide and randomised to multiple treatment combinations. The effects of interventions are assessed separately for moderate and severely ill patients.

The latest findings on tocilizumab and sarilumab add to REMAP-CAP findings from earlier this year, which found that hydrocortisone steroid treatment improved recovery among critically ill COVID-19 patients.*

*This study is one of a number of COVID-19 studies that have been given urgent public health research status by the Department of Health and Social Care. As of November 2020 75% of all study participants had been recruited in the UK through the NIHR’s Clinical Research Network (CRN).

The study is supported in the UK by the National Institute for Health Research (NIHR) and Imperial College London & ICNARC are partners in the EU funded PREPARE consortium.

Originally published by
Ryan O'Hare | January 7, 2021
Imperial College London

Original Article

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Gold Level Contributor
Running a full-scale model of an entire virus is computationally difficult, but a new framework created by University of Chicago scientists allows researchers to run a usefully simplified version to better understand how SARS-COV-2 works.    Credit Yu et al., “A Multiscale Coarse-Grained Model of the SARS-CoV-2 Virion,” Biophysical Journal (2021)

Pioneering multiscale model allows researchers to plug in and better understand information as new discoveries are made

Researchers at the University of Chicago have created the first usable computational model of the entire virus responsible for COVID-19—and they are making this model widely available to help advance research during the pandemic.

“If you can understand how a virus works, that’s the first step towards stopping it,” said Prof. Gregory Voth, whose team created the model published in Biophysical Journal. “Each thing you know about the virus’s life cycle and composition is a vulnerability point where you can hit it.”

Voth and his team drew on their previous experience to find the most important characteristics of each individual component of the virus, and drop the “less important” information to make a computational model that is comprehensive but still feasible to run on a computer. This technique is called coarse-graining, which Voth and his students have helped to pioneer.

The simplified framework helps address a key issue in health research: Even though a virus is one of the simpler biological entities, computational modeling is still a major challenge—especially if you want to model any of a virus’s interactions with its host’s body, which would mean representing billions of atoms.

“You could try running an atom-level model of the actual entire virus, but computationally it would bog you down immediately,” Voth said. “You might be able to manage it long enough to model, say, a few hundred nanoseconds worth of movement, but that’s not really long enough to find out the most useful information.”

Thus, many researchers have focused on creating models of individual proteins of the virus. But Voth said that while this segmented process has its uses, it also misses part of the larger picture.

“Each thing you know about the virus’s life cycle and composition is a vulnerability point where you can hit it.” —Prof. Gregory Voth

“The virus itself is a holistic thing,” said Voth, a computational scientist and the Haig P. Papazian Distinguished Service Professor of Chemistry. “In my opinion, you can’t assume you can look at individual parts in isolation. Viruses are more than just the sum of their parts.”

Voth said his lab has been working for years to model other viruses, such as HIV. One of the lessons they’ve learned is that multiple parts of the virus work in cooperation.

For example, scientists might investigate a drug that binds to the spike proteins on the virus surface to prevent them from attaching to the host’s cells. “One of the main things you might want to know is, do you need to dose every spike protein for it to work? If not, how low a percentage can you get away with?” Voth said. “This is a key question when you’re trying to create drugs or antibodies, and it’s something you can best understand by looking at the entire virus.”

The model also provides a framework into which scientists can integrate additional information about the SARS-COV-2 virus as soon as new discoveries are made.

Voth hopes that the model will prove useful for coronavirus drug design as well as understanding mutations that may arise, such as the one recently detected in the U.K. Anyone can download the model and use it for their research.

“Making a multiscale model of the whole virus and integrating all this information rapidly is a big technological step forward,” Voth said. “I’m really proud of my lab. We did it in record time, really—just a few months. If there is any upside to this pandemic, I hope that it advances our tools to fight viruses beyond COVID-19—like influenza, HIV and any new coronaviruses that arise in the future.”

Originally published by
Louise Lerner | January 6, 2021
uchicago News

The first author on the study was postdoctoral researcher Alvin Yu. Additional UChicago authors were Alexander Pak, Peng He and Viviana Monje-Galvan. Other co-authors were Lorenzo Casalino, Zied Gaieb, Abigail Doommer and Rommie Amaro with the University of California San Diego.

Computational resources were provided by the Research Computing Center at the University of Chicago, Frontera at the Texas Advanced Computer Center and the Pittsburgh Super Computing Center.

Citation: "A Multiscale Coarse-Grained Model of the SARS-CoV-2 Virion." Yu et al., Biophysical Journal, Jan 5. 2021, https://doi.org/10.1016/j.bpj.2020.10.048

Funding: National Science Foundation, National Institutes of Health, RCSA Research, UC San Diego Moore’s Cancer Center

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AI now sees and hears COVID in your lungs

DeepChest and DeepBreath, new deep learning algorithms developed at EPFL that identify patterns of COVID-19 in lung images and breath sounds, may help in the fight against other respiratory diseases and the growing challenge of antibiotic resistance.

For Dr Mary-Anne Hartley, a medical doctor and researcher in EPFL’s intelligent Global Health group (iGH), 2020 has been relentless. “It’s not a relaxing time to study infectious diseases,” she explained.

Since the beginning of the COVID-19 pandemic, Dr Hartley’s research team has been working non-stop with nearby Swiss university hospitals on two major projects. Using artificial intelligence (AI), they have developed new algorithms that, with data from ultrasound images and auscultation (chest/lung) sounds, can accurately diagnose the novel coronavirus in patients and predict how ill they are likely to become.

iGH is based in the Machine Learning and Optimization Laboratory of Professor Martin Jaggi, a world leading hub of AI specialists, and part of EPFL’s School of Computer and Communication Sciences. “We’ve named the new deep learning algorithms DeepChest – using lung ultrasound images – and DeepBreath – using breath sounds from a digital stethoscope. This AI is helping us to better understand complex patterns in these fundamental clinical exams. So far, results are highly promising,” said Professor Jaggi.

For Dr Mary-Anne Hartley, a medical doctor and researcher in EPFL’s intelligent Global Health group (iGH), 2020 has been relentless. “It’s not a relaxing time to study infectious diseases,” she explained.

Since the beginning of the COVID-19 pandemic, Dr Hartley’s research team has been working non-stop with nearby Swiss university hospitals on two major projects. Using artificial intelligence (AI), they have developed new algorithms that, with data from ultrasound images and auscultation (chest/lung) sounds, can accurately diagnose the novel coronavirus in patients and predict how ill they are likely to become.

iGH is based in the Machine Learning and Optimization Laboratory of Professor Martin Jaggi, a world leading hub of AI specialists, and part of EPFL’s School of Computer and Communication Sciences. “We’ve named the new deep learning algorithms DeepChest – using lung ultrasound images – and DeepBreath – using breath sounds from a digital stethoscope. This AI is helping us to better understand complex patterns in these fundamental clinical exams. So far, results are highly promising,” said Professor Jaggi.

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© Ivan Savicev - EPFL 2020 / iStock

Two university hospitals involved

CHUV, Lausanne’s University Hospital, is leading the clinical part of the DeepChest project, collecting thousands of lung ultrasound images from patients with Covid-19 compatible symptoms admitted to the Emergency Department. As principal investigator, Dr Noémie Boillat-Blanco explains that the project started in 2019, at first trying to identify markers that would enable better identification of viral pneumonia versus bacterial ones. However, the project took a more specific COVID focus in 2020. “Many of the patients who agreed to take part in our study were scared and very ill,” she said, “but they wanted to contribute to broader medical research, just like we do. I think there is a collective motivation to learn something from this crisis and to rapidly integrate new scientific knowledge into everyday medical practice.”

At HUG, the Geneva University Hospitals, Professor Alain Gervaix, M.D., Chairman, Department of Woman, Child and Adolescent has been collecting breath sounds since 2017 to build an intelligent digital stethoscope, the “Pneumoscope”. Originally designed as a project to better diagnose pneumonia, the novel coronavirus refocused its work. The recordings have now been used to develop the DeepBreath algorithm at EPFL. Expected to be released by the end of the year it should enable the diagnosis of COVID-19 from breath sounds. Amazingly, first results suggest that DeepBreath is even able to detect asymptomatic COVID by identifying changes in lung tissue before the patient becomes aware of them.

“Pneumoscope with the DeepBreath algorithm can be compared to applications which can identify music based on a short sample played. The idea came from my daughter when I explained to her that auscultation allows me to hear sounds which help me identify asthma, bronchitis or pneumonia,” said Professor Gervaix.

Coding skills from all over the world

The algorithms have been pre-published on the EPFL website but there is still much work to do. In March, Dr Hartley called on the EPFL community to help in a year-long hackathon called ‘CODED-19’. “We are continuing to refine and validate the algorithms as well as make the complex black box logic more interpretable to clinicians. We want to make robust, trustworthy tools that extend beyond this pandemic”. Work is also underway to develop an application that allows these complex deep learning algorithms to work on mobile phones, even in the most remote regions. She adds, “none of this work would have been possible without the incredible students and researchers from all over the world who have donated their time and expertise during a tumultuous period.” 

Hartley, Boillat-Blanco and Gervaix are moving forward to gather more data. COVID or not, pneumonia, which kills more than one million children every year, remains one of the leading causes of death of under-fives. It’s also one of the major drivers of antibiotic resistance, affecting mostly low-income countries and communities. Says Hartley, “we want to collect data from under-represented communities so that our tools can be accurate even in poor settings. Our algorithm is for instance specifically designed to tolerate errors in image or sound collection and inconsistent quality, which are more likely in those types of settings.” They are already working on extending these models to distinguish between viral and bacterial pneumonia with the hope of drastically reducing antibiotic use.

Motivated by the potential for decentralized patient management, significant improvements in health outcomes, lowered costs and a contribution to antibiotic stewardship, Hartley has self-funded a small number of data collection probes to take to tuberculosis areas in South Africa in early 2021 and is currently trying to raise money to implement the project more broadly.

“COVID has sensitized people to the vulnerability of public health, and its enormous complexity. The need to build large scale AI research efforts to understand and react to rapidly emerging data has never been more obvious. Let’s hope the momentum continues beyond the pandemic, and can be used to enable equitable access to health care,” Hartley concluded.

Originally published by
Tanya Peterson | December 3, 2020
EPFL

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A startup founded by an Imperial graduate has launched the first app to contribute to early diagnosis of dementia through artificial intelligence.

Mindset, founded by Imperial College London graduate Hamzah Selim, have launched the first version of their community-driven artificial intelligence (AI) dementia diagnosis app, giving everyone the chance to join the fight against dementia.  

Their mobile application screens for dementia by guiding the user through clinically validated diagnostic tests. Based on the National Institute for Health and Care Excellence (NICE) guidelines, Mindset screens for neurological anomalies and uses artificial intelligence to accurately flag clinically relevant findings.  

Distinguishing between normal and at-risk brains 

The team is currently collecting data on how the human brain works through the app, in both people with and without dementia. This will help to teach the AI how the brain works, what a healthy brain looks like and eventually to distinguish between normal and at-risk users.  

Currently around 850,000 people in the UK are living with dementia, with many more going undiagnosed. This has been exacerbated by the COVID-19 pandemic, with vulnerable people unable to access vital neurological care and struggling with mental health decline.  

With the app, patients answer a series of questions and complete cognitive exercises that mirror both the screening process and data collection that is usually done in person by a doctor.  

A common sign of dementia is a lack of vertical eye movement, which is usually assessed by asking the patient to follow a doctor’s finger. Mindset animates an object for the patient to track and uses the phone’s technology to quantify the user’s eye movement, mimicking a robust clinical analysis. By directly assessing a range of symptoms, the team can rely on more than just self-reported symptoms. 

Boosting efficiency

Speaking to the Evening Standard about the fear many older people may feel about going into a clinic or a hospital in current times, Hamzah said: "Mindset is on your phone.  It is completely safe.  It is never going to be as good as a neurologist, but it reduces the anxiety and provides a crucial portal of connection between patients and doctors."

He added: “It’s about taking the great parts of the NHS and putting it in your pocket and there’s lots of quirky ways to do that. It’s not about replacing doctors either but giving them a tool which can boost efficiency.”  

Increasing accessibility of neurological care 

The team hope that remote screening of dementia will increase accessibility of neurological care and allow clinicians to work safely while caring for a greater number of patients. Post-launch, they will construct a clinician interface for the app and attain a CE Mark which will allow Mindset to be fully integrated within the NHS as a screening tool. According to the team, this could significantly reduce NHS dementia-related spending, improve patient prognosis, and ensure care is accessible to all.  

Mindset was co-founded by Hamzah Selim, a graduate of Imperial’s BSc in Neuroscience and Mental Health, who is now a medical student at UCL. The team worked closely with Imperial’s Enterprise Lab and took part in 2019’s Venture Catalyst Challenge (VCC) competition.  

Originally published by
Joanna Wilson | November 27, 2020
Imperial College London

Image credit: Mindset

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Platinum Level Contributor

Thankful for Biopharma Breakthroughs

JAAGNet Comment:

We believe during these tough times, people and companies step up and understand the urgent need to go above and beyond. Although its been a pretty tough year with not a lot (if any) positive news there has been a lot of  people and bsuinesses working really hard to tackle  Covid-19, whether it has been in the area of theraputics and/or vaccines. The following article is a great summary of the breakthoughs that have been made and it shows us hope and promise that we can knock down the impacts this virus could have had on our global society.  Peter

 >>

For so many, 2020 has been a bleak year filled with uncertainty and anxiety directly related to the COVID-19 pandemic that has surged across the globe and led to the deaths of more than 1.4 million people, including close to 260,000 in the United States.

Despite the constant need for social distancing, mask-wearing, and the isolation and economic uncertainty that resulted from the outbreak, there is still much to be thankful for when families gather around a virtual table to break bread and carve the turkey this year. And one uniting bit of thankfulness the global community can share in is the prowess of the international pharmaceutical industry displayed to address COVID-19. Following the outbreak that originated in China, then spread across Asia and into Europe, the pharmaceutical industry pivoted on a dime to tackle the global threat. Ongoing research was put on the backburner and scientists began to focus on understanding the virus and assessing what medications could be used against it. The virus was also sequenced and hundreds of vaccine projects were initiated. The industry, along with scientists from various government agencies and academic institutions joined together in a united front against the global pandemic.

And those efforts are now beginning to pay off. In Russia and China, vaccines are already being distributed to front-line workers and manufacturing is ramping up for broader distribution. In the west, we are just weeks away from seeing the first coronavirus vaccine receive Emergency Use Authorization. The mRNA vaccine candidate developed by Pfizer and Germany-based BioNTech demonstrated 95% efficacy in clinical trials. The U.S. Food and Drug Administration (FDA) will review the data on Dec. 10.

When that medication is greenlit (as it most likely will be), the limited number of vaccines currently available will roll out within 24 hours and inoculation will begin. Fortunately, more vaccines will likely see approval in the United States and Europe, which means more people will receive some protection against the virus. Moderna reported vaccine efficacy of 94.5% and earlier this week, AstraZeneca also announced 90% efficacy from its vaccine candidate. Novavax and Johnson & Johnson are expected to release data soon, as will Merck and other companies.

The vaccine approvals are the proverbial light at the end of the tunnel that is COVID-19. High rates of inoculation will lead to herd immunity against the virus and that is something for which to be thankful.

But, it’s not just vaccines that have been developed for COVID-19. The FDA recently approved two antibody treatments for the virus, Eli Lilly’s bamlanivimab and Regeneron’s REGN-COV2, which had previously been used to treat the COVID-19 diagnosis of President Donald Trump. Both of the antibody treatments do have limits for their use. They are not meant for COVID-19 patients who require supplemental oxygen or are on ventilators.

Gilead Sciences' remdesivir broke through as the first COVID-19 drug to receive full approval from the FDA as a medication that can shorten the time of infection for infected patients. Despite its approval, Remdesivir has received a rocky reception, with the World Health Organization recommending against its use due to limited capabilities. Other drugs have also received similar receptions over the course of the pandemic. While remdesivir has clinical data supporting its approval, other medications such as hydroxychloroquine have only anecdotal data backing up any efficacy against the virus. Still, those COVID-19 patients who have benefited from the treatments are surely thankful for any edge against the virus they received.

COVID-19 has certainly dominated our landscape over the past nine months, but other illnesses continue to negatively impact the human condition. COVID research has been a primary focus, but that has not put a halt to the development of treatments for other diseases, including rare diseases.

This week, Alnylam won approval for Oxlumo (lumasiran), the first drug approved by the FDA for primary hyperoxaluria type 1, an ultra-rare genetic disease that causes deposits of calcium oxalate crystals to form in the kidneys and urinary tract, which can lead to painful and recurrent kidney stones, nephrocalcinosis, progression to kidney failure and system organ dysfunction. Also this week, the FDA approved Eiger PharmaceuticalsZokinvy, the first drug approved to treat Hutchinson-Gilford Progeria Syndrome and processing-deficient Progeroid Laminopathies. The two genetic diseases cause premature, rapid aging that dramatically decreases the lifespan of children affected. In June, Novartis became the first company to the finish line with a treatment for Adult-Onset Still’s Disease (AOSD), a rare auto-inflammatory disease of unknown origin. Ilaris (canakinumab), was previously approved for Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older.

These approvals and others not mentioned that improve quality of life and stave off premature death are all things the pharmaceutical industry and its countless, dedicated employees have provided for which we should be thankful.

Originally Published: Nov 26, 2020 By Alex Keown BioSpace

Original article can be found here

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When put up against five experienced, fellowship-trained radiologists, DeepCOVID-XR was able to process a set of 300 test X-rays in about 18 minutes compared to about two and a half to three and a half hours. (Getty Images)

Researchers at Northwestern University have trained an artificial intelligence algorithm to automatically detect the signs of COVID-19 on a basic X-ray of the lungs, and it’s capable of outperforming a team of specialized readers.

The developers said the AI could be used to rapidly screen patients upon admission to a hospital, especially for reasons unrelated to coronavirus symptoms, and trigger protocols to help protect healthcare workers.

“It could take hours or days to receive results from a COVID-19 test,” said Ramsey Wehbe, a cardiologist and postdoctoral fellow in AI at the Northwestern Medicine Bluhm Cardiovascular Institute. “AI doesn’t confirm whether or not someone has the virus. But if we can flag a patient with this algorithm, we could speed up triage before the test results come back.”

Called DeepCOVID-XR, the machine learning program was able to spot COVID-19 in X-rays about 10 times faster than thoracic radiologists and 1% to 6% more accurately.

“We are not aiming to replace actual testing,” said Aggelos Katsaggelos, the Joseph Cummings Professor of Electrical and Computer Engineering at Northwestern and senior author of the team’s study published in the journal Radiology. “X-rays are routine, safe and inexpensive. It would take seconds for our system to screen a patient and determine if that patient needs to be isolated.” 

Trained and tested on a data set of more than 17,000 X-ray images, the algorithm identified patterns in patients with COVID-19: Instead of a clear scan, their lungs appeared patchy and hazy as air sacs became inflamed and filled with fluid instead of air.

These are similar to cases of pneumonia, heart failure or other pulmonary conditions, but the AI was able to tell the difference and spot the contagious disease. Still, there’s a limit to radiologic diagnosis, as not all carriers of COVID-19 may show signs of illness, especially during the early stages of an infection.

“In those cases, the AI system will not flag the patient as positive,” said Wehbe. “But neither would a radiologist.”

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Chest X-rays and AI overlays provided by DeepCOVID-XR (Northwestern University) 

When put up against five experienced, fellowship-trained radiologists, DeepCOVID-XR was able to process a set of 300 test X-rays in about 18 minutes, compared to about two and a half to three and a half hours. The AI also delivered an accuracy rate of 82%, about on par with the group’s range of 76% to 81%.

Additionally, the researchers have made the algorithm publicly available, allowing others to train it with new data, with the goal of eventually getting the program into the clinic.

“Radiologists are expensive and not always available,” Katsaggelos said. “X-rays are inexpensive and already a common element of routine care. This could potentially save money and time—especially because timing is so critical when working with COVID-19.”

Originally published by
Conor Hale | November 25, 2020
Fierce Biotech

 

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Research efforts in Florida will be a model for how Berg and AdventHealth roll out similar work throughout the U.S. The Berg artificial intelligene platform can provide info on why conditions such as obesity and diabetes leave people more vulnerable to COVID-19. (AdventHealth)

AdventHealth has partnered with biotech firm Berg to gain insights on people that have tested positive for COVID-19 and reduce mortality rates from the disease.

AdventHealth, a nonprofit health system based in Orlando, Florida, has diagnosed and treated more than 25,000 patients with COVID-19 to date. With more than 250,000 Americans having died during the COVID-19 pandemic, a key reason for Berg to work with AdventHealth is to understand COVID-19 better and also help triage patients suffering from the virus, explained Niven Narain, Ph.D., co-founder, president and CEO of Berg.

Under the agreement announced Monday, the two organizations will use Berg’s proprietary artificial-intelligence-enabled Interrogative Biology platform with AdventHealth’s patient data. Narain explained that the platform processes biological patient samples on the front end and feeds that into a back-end AI analytical platform. It incorporates machine learning as well as a type of AI called a Bayesian network. With ML, data scientists generate data insights from a hypothesis, but with Bayesian AI the data generate the hypothesis. You then validate the hypothesis in the laboratory and with clinical records, Narain told Fierce Healthcare.

AdventHealth and Berg will build a patient registry biobank that will allow data scientists to find the best treatments for patients with COVID-19. The biobank will incorporate data on all patients that have undergone COVID-10 tests at AdventHealth. Data scientists will study the length of hospital or ICU stays and which medications the health system administered as well as personal medical history and patient outcomes.

Research efforts in Florida will be a model for how Berg and AdventHealth roll out similar work throughout the U.S. The Berg AI platform can provide info on why conditions such as obesity and diabetes leave people more vulnerable to COVID-19, according to Steven Smith, M.D., senior vice president and chief scientific officer at AdventHealth.

Growing an existing relationship

AdventHealth had already been using Berg’s technology to boost outcomes and develop precision medicine for patients with nonalcoholic fatty liver disease (NAFLD) and sarcopenia, which is a reduction in skeletal mass due to aging. Data scientists from Berg and AdventHealth will collaborate in a similar way with a focus on the COVID-19 pandemic.

“We already had a relationship, and this just allowed us to magnify and grow that,” Smith told Fierce Healthcare.

While the work on NAFLD and sarcopenia was primarily focused on drug discovery and development, for the COVID-19 research, Berg and AdventHealth have developed a data lake from which they have pulled information on positive COVID-19 cases, Smith explained.

The biobank patient registry will launch in two phases: In the first phase, the organizations will release patient demographics, COVID-19 clinical information and patient medical histories. In the second phase, the organizations will incorporate data from across AdventHealth locations in multiple U.S. states. They will also analyze how chronically administered medications could be linked with a better outcome or lower probability of SARS-CoV-2 infection, the strain of coronavirus responsible for COVID-19.

Gaining insights from AI

A desired result of the research is to generating risk engines and understand how to triage patients better, Smith noted.

“There are a few risk engines out there in the literature,” Smith said. “They perform OK—they're not great—so there's certainly the potential for advancement in that way.”

Smith’s team at AdventHealth will receive updates from Berg on the data approximately every 30 days as the second wave of the COVID-19 crisis gets underway, according to Narain.

“This is what makes this so important because the next few months are going to be presumably very difficult, and our goal of this project is to try to deliver insights and answers while this is all going on,” Narain said. “As quickly as we get it, we’ll be feeding it into the system and every 30 days or so update the insight.”

The AI data will inform doctors regarding which medications, like remdesivir and dexamethasone, work on certain populations, Narain explained.  

“It will bring together the efficiency among physicians, patients, and drug developers so that the ecosystem of information sharing becomes easier,” Narain said.

Smith added that the advantage of AI is to be able to provide key insights in a way researchers didn’t anticipate.

“The broad idea of AI layered on top of rich data is to be able to break those chains so to speak around how we think about particular illnesses and flip that upside down,” Smith said.

Originally published by
Brian T. Horowitz | 
Nov 23, 2020
Fierce Healthcare

 

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Stanford engineers have created a microlab half the size of a credit card that can detect COVID-19 in just 30 minutes. (Image credit: Getty Images)

Throughout the pandemic, infectious disease experts and frontline medical workers have asked for a faster, cheaper and more reliable COVID-19 test. Now, leveraging the so-called “lab on a chip” technology and the cutting-edge genetic editing technique known as CRISPR, researchers at Stanford have created a highly automated device that can identify the presence of the novel coronavirus in just a half-hour.

“The microlab is a microfluidic chip just half the size of a credit card containing a complex network of channels smaller than the width of a human hair,” said the study’s senior author, Juan G. Santiago, the Charles Lee Powell Foundation Professor of mechanical engineering at Stanford and an expert in microfluidics, a field devoted to controlling fluids and molecules at the microscale using chips.

The new COVID-19 test is detailed in a study published on Nov. 4 in the journal Proceedings of the National Academy of Sciences. “Our test can identify an active infection relatively quickly and cheaply. It’s also not reliant on antibodies like many tests, which only indicates if someone has had the disease, and not whether they are currently infected and therefore contagious,” explained Ashwin Ramachandran, a Stanford graduate student and the study’s first author.

The microlab test takes advantage of the fact that coronaviruses like SARS-COV-2, the virus that causes COVID-19, leaves behind tiny genetic fingerprints wherever they https://news.stanford.edu/go in the form of strands of RNA, the genetic precursor of DNA. If the coronavirus’s RNA is present in a swab sample, the person from whom the sample was taken is infected.

To initiate a test, liquid from a nasal swab sample is dropped into the microlab, which uses electric fields to extract and purify any nucleic acids like RNA that it might contain. The purified RNA is then converted into DNA and then replicated many times over using a technique known as isothermal amplification.

Next, the team used an enzyme called CRISPR-Cas12 – a sibling of the CRISPR-Cas9 enzyme associated with this year’s Nobel Prize in Chemistry – to determine if any of the amplified DNA came from the coronavirus.

If so, the activated enzyme triggers fluorescent probes that cause the sample to glow. Here also, electric fields play a crucial role by helping concentrate all of the important ingredients – the target DNA, the CRISPR enzyme and the fluorescent probes – together into a tiny space smaller than the width of a human hair, dramatically increasing the chances they will interact.

“Our chip is unique in that it uses electric fields to both purify nucleic acids from the sample and to speed up chemical reactions that let us know they are present,” Santiago said.

The team created its device on a shoestring budget of about $5,000. For now, the DNA amplification step must be performed outside of the chip, but Santiago expects that within months his lab will integrate all the steps into a single chip.

Several human-scale diagnostic tests use similar gene amplification and enzyme techniques, but they are slower and more expensive than the new test, which provides results in just 30 minutes. Other tests can require more manual steps and can take several hours.

The researchers say their approach is not specific to COVID-19 and could be adapted to detect the presence of other harmful microbes, such as E. coli in food or water samples, or tuberculosis and other diseases in the blood.

“If we want to look for a different disease, we simply design the appropriate nucleic acid sequence on a computer and send it over email to a commercial maker of synthetic RNA. They mail back a vial with the molecule that completely reconfigures our assay for a new disease,” Ramachandran said.

The researchers are working with the Ford Motor Company to further integrate the steps and develop their prototype into a marketable product.

Originally published by
Andrew Myers | November 4, 2020
Stanford News | Stanford University

Original article

Santiago is a member of Stanford Bio-X and a faculty fellow in ChEM-H. Ramachandran is a Bio-X graduate student fellow. Additional Stanford contributors include doctoral scholar Diego A. Huyke, postdoctoral scholar Eesha Sharma, research scientist Malaya K. Sahoo, research scientist ChunHong Huang of the Department of Pathology, Professor of Pathology Niaz Banaei, Professor of Pathology Benjamin A. Pinsky.

This research received financial support from the Stanford Chemistry Engineering & Medicine for Human Health (ChEM-H) program and from Ford Motor Company.

 

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Bronze Level Contributor

© 2020 EPFL

Scientists at EPFL are using technology to better understand how coronavirus causes blood clots in some patients. They have developed a simplified model of a lung that lets them observe, for the first time, how the virus attacks the cells lining blood vessels.

COVID-19 sometimes causes blood clots, although the exact incidence remains a mystery. A recent study indicates that around 10% of hospitalized patients develop this complication. Doctors still aren’t sure why the virus provokes this reaction – in the most severe cases, the blood clots can lead to a stroke. To get more insight into this phenomenon, EPFL scientists have developed a microfluidic chip that models the human lung and replicates part of its structure to study COVID-19 infections The chip can hold lung epithelial cells, blood-vessel cells and immune-system cells, and lets scientists directly watch how SARS-CoV-2 attacks human cells and triggers the formation of blood clots.

Two mechanisms are suspected to be at work. One is an excess production of cytokines, which are proteins that play a role in immune-cell signaling. Coronavirus can cause the “cytokine storms,” which have been much discussed in the news. These disproportionate immune system reactions can damage blood vessels and cause blood clots to form, and are potentially fatal. The other possible mechanism is damage to the interior lining of blood vessels – or the endothelium – in the lungs. The lungs have a lot of this kind of tissue, and when it’s damaged, blood can coagulate easily and form clots.

So which mechanism is the likely culprit? To find out, doctors need to be able to watch how the infection progresses in the lungs hour by hour. That’s nearly impossible in living patients and not very feasible in lab cultures either, since cultures usually contain just one kind of cell and don’t provide a realistic enough representation of the entire lung system.

Scientists in the lab of Prof John McKinney have received the support from the EPFL COVID-19 Task Force. Led by Dr Vivek Thacker, a postdoc in the lab, they have now taken a lung-on-a-chip device and adapted it to model the individual steps in a SARS-CoV-2 attack on the lungs. The device contains microfluidic channels that feed nutrients to cells on the chip, which are arranged to recreate a section of the lungs. More specifically, the chip contains a layer of epithelial cells, or the cells coating the lungs, along with a layer of endothelial cells, or the cells lining the blood vessels. The two layers are separated by a membrane.

After the scientists introduced SARS-CoV-2 into their device, the virus first attacked the outside layer of epithelial cells, just like in a natural infection. Working with Dr Jessica Sordet Dessimoz and her team in the Histology Core Facility, they found that within a day the virus had reached the inner layer of endothelial cells and caused considerable damage over subsequent days.

“There was enough damage to destroy the endothelium and expose blood in the vessels to air, causing clots to form,” says Vivek Thacker. “With our lung-on-a-chip system, we found that the virus may be causing blood clots by attacking the endothelium directly. However, that doesn’t mean that cytokines don’t play a role too and make things worse.” These initial findings have been written up in a paper currently under review.

The EPFL device has revealed a phenomenon that can’t be observed using conventional methods, since SARS-CoV-2 doesn’t proliferate well in endothelial cell monocultures. “Some virus particles have also been found in the endothelium of infected patients, but the amounts are very small,” says Thacker.

The team will next use their lung-on-a-chip with actual blood samples so that they can observe clot formation directly. And that’s not as easy as it sounds – blood coagulates very quickly outside the body, so “we’ll have to be fast and accurate,” explains Thacker. They plan to add an anticoagulant to the samples and then neutralize it just before injecting the samples into the device. The team will work on this complicated procedure in the next few weeks.

Originally published by
Lionel Pousaz | October 7, 2020
EPFL

 

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Adeline Kon/MedTech Dive

Permanent adoption of remote tech, changes to clinical trials and rethinking where medtech employees work are among the phenomena poised to stick around.

Come early 2021, the medtech sector will have three quarters of data charting the downturn and recovery in the wake of COVID-19. Regardless of the path forward — a V, a W or something in between — the sharpest of impacts is expected to have peaked in spring 2020.

But the pandemic will no doubt shape medtech business decisions in the coming months and years as constraints on healthcare systems, economies and ways of working and living linger.

Below MedTech Dive lays out key areas of industry operations that the COVID-19 environment will likely affect in the year to come.

1. Direct-to-consumer campaigns

Ads hawking medical devices are far less common than for drugs, but a few companies have noticeably ramped up their direct-to-consumer efforts in recent years, including Boston Scientific with a rare medtech TV ad for an implant aimed at reducing stroke and Stryker making a social media play with elite athlete Alex Morgan.

While FDA has weighed in on ethics and best practices of direct-to-consumer advertising for drug manufacturers, it's less fleshed out for the device industry. AdvaMed has tried to get ahead of things, last year updating voluntary principles for marketers.

During COVID-19, the proliferation of DTC marketing by medtech companies has been multifaceted.

First, companies across the healthcare spectrum have launched broad campaigns urging consumers to return to seek care after distancing measures and fear over virus transmission in healthcare settings spurred a severe downturn in lucrative elective procedures.

LabCorp, Walgreens, Humana and others urged patients to Stop Medical Distancing this summer, for example. Hologic aligned with singer-songwriter Sheryl Crow with its Back to Screening campaign, encouraging consumers to schedule mammograms as healthcare facilities were reopening for imaging. Johnson & Johnson in September launched its own take on the effort dubbed My Health Can't Wait.

"We're really not focusing on any specific therapeutic area or any specific procedure," said Jijo James, chief medical officer at J&J Medical Devices, who worked on the campaign. It includes resources pointing patients toward telehealth options and suggestions on how to talk to a doctor about again seeking care.

Abbott took to the airwaves in April as it was being thrust into the national spotlight for its outsized role in America's coronavirus testing ramp-up. A 30-second TV spot looked to elevate the brand name while expressing gratitude to healthcare workers.

Separate from the COVID-19 theme itself, some companies saw the pandemic as an opportune time to target new customers, particularly as many spend more time engaging with media.

Dexcom, for example, is not slowing down its continuous glucose monitor marketing. "We'll continue to invest aggressively there to get the word out," said Matt Dolan, the company's head of new markets. "There's so many folks that that haven't even heard of it. And so it's very important that we continue to drive those campaigns."

Likewise, Exact Sciences CEO Kevin Conroy told investors in July the company expects to spend $70 million this year on television advertising alone. The company's signature product, colorectal cancer stool test Cologuard, remained an option for screening even as the rate of colonoscopies dropped dramatically.

That's one example of a medtech product that aligns well with the pandemic-driven expansion of telehealth. Jay Zhu, who leads the Medtech Commercial Strategy practice at Deloitte, said now is a time for those types of companies that typically compete with doctor's office or hospital-based treatments to capitalize.

"They see this as the golden opportunity for them to accelerate a shift" and are backing direct-to-consumer communication "to basically convince patients that now is the perfect time to use these kinds of less risky solutions."

A bit newer to consumer-focused advertising, Teleflex CEO Liam Kelly said this summer that as non-emergent procedures appeared to return, it decided to run a pilot national campaign from July to December for its UroLift device for enlarged prostate. "Our regional digital DTC efforts indicated strong patient engagement in June, along with positive sentiment from clinicians, both of which gave us confidence in the July launch," Kelly told investors.

2. Rethinking physical footprints

Like myriad other industries, distancing measures are reshaping where and how employees work, prompting medtech leaders to rethink their companies' footprints.

Stryker CEO Kevin Lobo told investors in July that while much of its capital spending in recent years went toward office buildings, particularly as Stryker has acquired companies and people, that trend is poised to change.

"We're going to embrace flexible work arrangements going forward, and we are not going to need the same real estate by any stretch that we have today," Lobo said. "Frankly, we're seeing a big change of what's going to be required in the future."

According to Eddie Rymer, a principal at commercial real estate firm Avison Young in medtech hub Minneapolis, many companies are taking a wait-and-see approach when it comes to making decisions. A "hybrid model" of embracing virtual work-from-home strategies part time for some employees while getting more essential workers back together is likely, Rymer said.

One strategy that Rymer is seeing implemented are sale leasebacks — when companies sell a building to investors to free up cash, only to lease it back instead.

JLL's Roger Humphrey, global lead of the firm's life sciences practice, echoed the current state of limbo. "A lot of our clients have put a lot of of their projects on hold, with respect to office space," Humphrey said.

And there's still the school of thought that medtech is competing with big tech for talent, and that attractive work environments remains a pull for winning top candidates. Humphrey, pitching a more optimistic outlook for real estate, noted that even as companies get more critical about how many people need to be working in the same space on a given day, the social distancing mindset and need to reduce density may balance that out.

On the manufacturing side, Humphrey thinks the supply chain lessons from the pandemic will continue to drive a desire for reshoring, and foresees Puerto Rico only growing in popularity. Humphrey also noted that North Carolina, Georgia and New Jersey are all potential targets for an uptick in medtech manufacturing, as they all have life sciences manufacturing infrastructure from 10 or 15 years ago before lots of production was transferred overseas

3. Remote medtech's post-pandemic future

Before the pandemic, remote programming and monitoring of an array of devices was becoming increasingly important. However, these features have become paramount.

Given unprecedented FDA regulatory flexibility, Medtronic, Philips, ResMed and others modified existing products so frontline providers could reduce virus exposure.

Medtronic worked with tech giant Intel and created a new remote management capability for its Puritan Bennett 980 ventilator to allow providers to adjust the breathing machine's settings outside of hospital intensive care units and away from patients.

"We're seeing hospitals talk about making that standard of care," Medtronic CEO Geoff Martha told investors during a late May conference call, adding that it's not a question of if that happens but when.

ResMed similarly developed cloud-based remote monitoring software for ventilators across Europe, providing clinicians with access to respiratory information using their smartphones.

FDA issued guidance in April expanding the remote monitoring and manual control of infusion pumps. In March, the agency also issued an enforcement policy, revised in June, to expand the availability and capability of non-invasive remote monitoring devices to support patient monitoring during the public health emergency. The guidance applies to legally marketed devices that measure and detect common physiological parameters, including electronic stethoscopes, oximeters, and EKG and blood pressure devices.

"The gist of the policy in this guidance is outlining how FDA does not intend to object to certain modifications to the indications, claims, functionality, hardware or software, of these devices" without prior submission of a premarket notification to the agency, said Jessica Paulsen, director of FDA's division of cardiac electrophysiology, diagnostics and monitoring devices.

Allowing manufacturers to change the indications or claims to allow for the use of devices in a home setting has been "a big one" during the pandemic, according to Paulsen.

Paulsen hastened to note that the COVID-19 guidance for non-invasive remote monitoring devices is one of many such policies issued by FDA only intended to remain for the duration of the public health emergency.

Still, some solutions will no doubt become permanent parts of the healthcare landscape after the crisis ends and FDA's emergency use authorizations have expired. Medtechs have either already sought out lasting FDA marketing authorization for such products or are in the planning process.

Philips in May received 510(k) clearance from FDA for a wearable biosensor to help monitor the heart and respiratory rate of hospitalized COVID-19 patients. The sensor, which has a CE mark, provides surveillance alerting clinicians of the risk of a patient's condition deteriorating.

Nearly overnight, COVID-19 has forever changed the status quo for how healthcare providers treat patients remotely with medtech. It's a trend that will continue to improve future care as the U.S. health system looks to drive down healthcare costs through remote monitoring and to increase patient access to care.

4. Clinical trials go remote

Remote technologies have also been extended to clinical trials — a trend that preceded the crisis but has accelerated since.

The scalability and deployability of the technology for clinical trials means that literally thousands of patients can be remotely monitored 24/7 to keep abreast of their conditions following a procedure involving the use of medical devices. All this patient-generated data is analyzed to establish clinically significant findings for devices in head-to-head or standalone studies.

"This is the wave of the future," said Brijeshwar Maini, national medical director of cardiology at Tenet Healthcare and professor of medicine at Florida Atlantic University.

In particular, Maini sees the value of remote monitoring and telehealth to optimize clinical outcomes and increase patient satisfaction following transcatheter aortic valve replacement procedures.

Maini is principal investigator for a first-of-its-kind study of 100 patients undergoing TAVR whose primary objective is to measure the impact of these digital technologies on patient satisfaction, clinical outcomes and hospital readmission rates.

The prospective trial, Telemedicine for Symptom Tracking And Decrease Readmission Rate in TAVR Patients (TELESTAR-TAVR), will monitor patients in real time for cardiac arrhythmia — a predictor for readmission — and signs of early deterioration. Participating physicians will have discretion as to which TAVR devices will be used for specific patients.

Remote and wearable biosensor company VitalConnect is providing the technology including disposable patches used to monitor vital signs, EKG and 19 different arrhythmias, as well as a mobile device to transmit data from the patches to the cloud and a web-accessible central monitoring interface.

"All of those data points will be live streaming back to the caregiver's computer and central command station," said VitalConnect CEO Peter Van Haur.

Patients enrolled will be discharged within 24 hours of their procedure and monitored at home for seven days with the biosensor. They will then connect with their physician via video call and, finally, at 30 days, return to the hospital for follow up.

Maini points to a pivotal trial launched in 2019 to evaluate the safety and effectiveness of Abbott's TriClip transcatheter tricuspid valve repair system for the treatment of severe tricuspid regurgitation as an example of such remote patient monitoring. It is the first pivotal Investigational Device Exemption trial in the U.S. to evaluate a catheter-based, non-surgical treatment for patients with the condition.

In that Abbott trial, Maini notes that about 700 patients will be randomized to receive either the TriClip device or medical therapy and followed for a total of five years.

The TELESTAR-TAVR study, launched in September, was planned prior to the pandemic and ended up having a delayed start as a result of the outbreak, according to Maini.

COVID-19 has disrupted over 1,200 clinical trials and about a third have resumed, according to analytics company GlobalData. Although suspended trials have begun to recruit participants, GlobalData reports delays in trial initiation and slow recruitment continues.

"The clinical trials that could be conducted successfully on a remote basis were able to continue," observed Ira Bahr, COO of digital health company AliveCor. At the same time, Bahr said there are still some studies that are suspended "because they don't have the means of doing what needs to be done remotely."    

Nonetheless, Kuldeep Singh Rajput, CEO of digital health company Biofourmis, which leverages a wearable medical-grade biosensor to gather patient data, said that despite the initial impact, about 80% of the clinical trials it is involved in have converted from traditional protocols to virtualized studies.

"Of course there were some hiccups earlier this year, but now those studies are going as planned and are recruiting patients," Rajput said.

FDA issued guidance in March, updated in September, for industry, investigators and institutional review boards on conducting clinical trials during the COVID-19 pandemic. Since trial participants may not be able to come to the investigational site for protocol-specified visits, the agency has recommended that sponsors evaluate alternative methods for safety assessments including virtual visits and remote monitoring.  

"The market has fast-forwarded by almost five to six years" with the use of remote-virtual tech, commented Rajput. As a result, he says endpoints are being met much more quickly compared to the traditional ways of conducting clinical trials. "You can do continuous vital signs monitoring using sensors, so patients don't need to come back for office visits. And, you can do virtual visits now using telehealth capabiltiies," Rajput said.   

5. HHS changes LDT policy for COVID-19 and beyond

For diagnostics, there may be no regulatory change over the course of the pandemic with potential for more disruption than the August decision that FDA will no longer require premarket review for laboratory-developed tests.

The HHS policy change said laboratories can voluntarily seek approval, clearance or emergency use authorization for an LDT, but they are no longer required to do so. The department cited regulatory flexibilities amid the pandemic as backing the change.

But experts like Scott Gottlieb, former FDA commissioner, warn the regulatory agency's ability to protect public health could be significantly impaired. Gottlieb on Twitter predicted a barrage of direct-to-consumer coronavirus tests will enter the market and be "processed in a central lab operating outside FDA oversight."

The change reverses a long-established FDA regulation and applies to all LDTs, not just COVID-19 diagnostics.

A senior AdvaMed official speaking on background called the move "the wrong call." The lobbying group is concerned that all diagnostic test developers, of both IVDs and LDTs, will not be subject to the same standard of testing validation during the pandemic and beyond.

While the American Clinical Laboratory Association, which represents companies most impacted by the LDT policy changes, said it appreciated HHS' recognition of flexibility for laboratories to innovate, the group argued it must be balanced with bringing to market quality testing services.

The Association for Clinical Oncology in September warned the HHS policy change threatens the safety of cancer care.

"The failure to develop reliable tests that perform as intended, could lead to patients receiving an inappropriate and potentially harmful treatment, or alternatively, not receiving a treatment that has the potential to be beneficial," said ASCO's Chair Monica Bertagnolli, who called for a regulatory framework that includes a risk-based approach to oversight in which LDTs are thoroughly validated.

Democratic lawmakers are looking into it as well. House Energy Committee Chairman Rep. Frank Pallone, D-N.J., in August demanded a briefing from HHS Secretary Alex Azar on the change.

Prior to the HHS policy change in August, Congress had been working on the regulation of LDTs. The Verifying Accurate, Leading-edge IVCT Development (VALID) Act introduced in March in both the House and Senate creates a new test product category, in vitro clinical tests, which include lab-developed tests, while giving FDA authority to review and approve IVCTs.

AdvaMed backs the legislation and is working with the bipartisan cosponsors in both chambers of Congress "so that all diagnostic tests are subject to the same modernized, risk-based, scientifically rigorous, and efficient regulations in order to ensure quality and patient safety."

Likewise, ACLA President Julie Khani in a statement said the VALID Act is critical to achieving "common sense, comprehensive diagnostic reform" through Congress that will enable "our ability to tackle the most challenging and complex health needs of the country."

Originally published by
Maria Rachal - Greg Slabodkin | October 1, 2020
Medtech Dive

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Gold Level Contributor

Typically swallowed in front of healthcare professionals, the FDA said it would exercise its enforcement discretion to allow the unsupervised administration of CapsoVision's capsule-based endoscope, which is distributed by Pentax in Canada and the U.S. (FDA)

 

CapsoVision—maker of an ingestible camera pill for scanning the inside of a person’s gastrointestinal tract—has received word from the FDA that they may offer their device for fully remote, at-home use during the COVID-19 pandemic.

Since the spread of the novel coronavirus, the agency has sought various ways to lessen the amount of physical contact between patients and healthcare providers by promoting the use of digital technologies and connected devices.

"CapsoVision's advanced capsule technology delivers high-quality diagnostic images without creating a risk of in-person exposure to COVID-19," said Johnny Wang, the company’s president and chief technology officer. “Our team is proud to contribute during the pandemic and to continue to innovate within the emerging telehealth paradigm."

Typically swallowed in front of healthcare professionals, the FDA said it would exercise its enforcement discretion to allow the unsupervised administration of the capsule-based endoscope, which is distributed by Pentax in Canada and the U.S.

The self-contained CapsoCam Plus records 360-degree images of the mucosal lining of the small intestine using four panoramic cameras. It’s designed to spot abnormalities such as ulcers or active bleeding as well as the signs of celiac disease.

The user does not need to wear any external equipment, such as a sensor belt or receiver, and the device with images on board is simply returned to the clinic after a matter of hours. The findings are then reviewed by physicians through the company’s cloud-based system.

Originally published by
Conor Hale | September 28, 2020
Fierce Biotech

 

 

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Cellex's app will help automatically report results to public health authorities to aid in contact tracing while giving users who have tested negative a mobile pass showing the result. (Shutterstock)

Diagnostic maker Cellex has announced plans to develop a rapid coronavirus infection test that people can fully perform at home, from sample collection to result—with 15-minute readings double-checked by a personal smartphone app.

The company is partnering up with Gauss, a developer of machine vision-based healthcare programs, to help digitize the results of its upcoming COVID-19 antigen test.

Cellex said it is currently working to validate its diagnostic, which has previously shown a false negative rate of about 10% while returning no false positive results, through clinical trials.

Meanwhile, the smartphone app from Gauss aims to provide step-by-step video instructions on how to self-collect a nasal swab sample and perform the test. After 15 minutes, the app prompts the user to scan the result using the smartphone’s camera, which reads the image and confirms whether it is positive or negative. 

“This AI-enabled COVID-19 antigen test for home use will make self-monitoring and isolation feasible, thereby playing a significant role in changing the trajectory of the COVID-19 pandemic in America and beyond,” said James Li, founder and CEO of Cellex, which previously received the FDA’s first emergency authorization for a rapid COVID-19 antibody blood test in April.

The app will also help automatically report results to public health authorities to aid in contact tracing while giving users who have tested negative a mobile pass showing the result. Outside of the home, when used by healthcare professionals, the app can send results to a patient’s electronic health record.

“By embedding advanced computer vision algorithms within a thoughtfully-designed user experience, we can enable consumers to perform a rapid test in their own homes just as well as a trained operator or a laboratory instrument—simply by using their smartphone cameras,” Gauss founder and CEO Siddarth Satish said.

Cellex and Gauss said they aim to have the antigen test and companion app authorized by the FDA this fall.

Originally published by
Conor Hale | September 17, 2020
Fierce Biotech

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Courtesy of Roche

Roche's COVID-19 and influenza A/B test for use on the Swiss company's benchtop Cobas Liat system has received an emergency use authorization from the FDA. 

The rapid diagnostic, which gives results for single samples within 20 minutes, is the second EUA for the Roche combination test. The company's Cobas SARS-CoV-2 & Influenza A/B test, designed to run on its 6800/8800 systems and provide 96 results in about three hours, got FDA's nod earlier this month.

With the approaching flu season, the latest EUA for the Roche test gives the new option of conducting rapid testing in either point-of-care or clinical laboratory settings to detect and differentiate between the viruses. It is the FDA's fifth emergency authorization for such a combination diagnostic.

Dive Insight:

FDA in July granted emergency authorization to a test developed by the Centers for Disease Control and Prevention to determine if a patient is infected with the flu or the novel coronavirus. The agency previously authorized similar combination tests from BioFire Diagnostics and Qiagen in the spring. However, the two EUAs Roche has received in as many weeks are the first for such a major testing manufacturer.  

The latest EUA provides Roche with an authorized rapid diagnostic to help healthcare providers distinguish between the contagious respiratory illnesses caused by different viruses.

The test is to be used with provider-collected nasopharyngeal and nasal swabs and self-collected nasal swabs, collected in a healthcare setting with instruction by a provider, from individuals suspected of respiratory viral infection consistent with COVID-19, according to FDA.

The ability of Roche's system to provide results for single samples within 20 minutes in POC and clinical lab settings is a much faster combo test than the one authorized earlier this month. At the time, Roche claimed the EUA to be the first for a commercial diagnostic that runs on fully automated high-throughput systems and can discern between the three viruses in a single sample.

Originally published by
Greg Slabodkin | September 16, 2020
MedtechDive

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Generate said that, over a period of 17 days, it was able to design 100 potential antibodies for the novel coronavirus and narrow them down to the ones with the best chance of binding to its spike protein and slowing its spread. (Image: NIAID - Rocky Mountain Laboratories)

After raising $1.1 billion earlier this year to back a new slate of biotechs, Flagship Pioneering has raised the curtain on an artificial intelligence company focused on discovering and designing a wide range of new drugs. 

Generate Biomedicines will use a machine learning platform, developed under-the-radar over the past three years, to help parse the structure of thousands of human proteins and create novel protein sequences that could form the basis of new treatments.

The company also plans to use its generative chemistry and biology systems to invent new therapies taking the form of AI-designed antibodies, peptides, enzymes and cytokines, as well as developing new gene-editing technologies.

"Breakthroughs in machine learning algorithms, the exponential growth in computing power, and the acceleration and democratization of DNA sequencing and DNA synthesis are allowing us to learn from biology at unprecedented scale," said Flagship’s founder and CEO, Noubar Afeyan. 

"Protein design is not a new idea, but it has been frustrated by the limitations of previous technologies,” Afeyan added. “Generate Biomedicines was formed to move biomedicine past its dependence on existing discovery methods and develop a new machine learning technology that can generate biologic drugs for potentially any target, in order to treat previously intractable diseases."

The company was co-founded in 2018—by Flagship’s Avak Kahvejian, Geoffrey von Maltzahn, Molly Gibson and Gevorg Grigoryan, who also maintains a lab at Dartmouth University—after two Flagship Labs projects focused on creating drugs out of proteins were merged together. 

"Generate began with the question, 'What if we could generate novel protein therapeutics using new computational tools without having to discover them through trial and error?'" said von Maltzahn, who will serve as co-CEO along with Kahvejian.

"In much the same way that the patterns found in large libraries of songs, texts or photographs have been used to create AI-generated music, language and faces, we have shown that patterns in protein sequences and structures can be broadly applied to generate novel biomedicines,” he said.

Generate said it has begun constructing a portfolio of candidates that it plans to develop itself as well as put up for partnerships with other biopharma companies. 

This includes potential therapies for COVID-19, including antibodies and peptides that target the novel coronavirus’ spike protein, which is used to enter and infect human cells. The company said that, over a period of 17 days earlier this year, it was able to generate 100 potential antibodies and narrow them down to those with the best chance of binding to the virus and slowing its spread.

That project will continue its work in collaboration with the Coronavirus Immunotherapy Consortium, an initiative led by the La Jolla Institute for Immunology and supported by the COVID-19 Therapeutics Accelerator, launched earlier this year by the Bill & Melinda Gates Foundation, the Wellcome Trust and Mastercard.

Originally published by
Conor Hale | September 11, 2020
Fierce Biotech

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Researchers from MIT and Brigham and Women’s Hospital hope to reduce the risk to healthcare workers posed by Covid-19 by using robots to remotely measure patients’ vital signs.
Credit: Spot image courtesy of the researchers, edited by MIT News

The research described in this article has been published on a preprint server but has not yet been peer-reviewed by scientific or medical experts.

During the current coronavirus pandemic, one of the riskiest parts of a health care worker’s job is assessing people who have symptoms of Covid-19. Researchers from MIT and Brigham and Women’s Hospital hope to reduce that risk by using robots to remotely measure patients’ vital signs.

The robots, which are controlled by a handheld device, can also carry a tablet that allows doctors to ask patients about their symptoms without being in the same room.

“In robotics, one of our goals is to use automation and robotic technology to remove people from dangerous jobs,” says Henwei Huang, an MIT postdoc. “We thought it should be possible for us to use a robot to remove the health care worker from the risk of directly exposing themselves to the patient.”

Using four cameras mounted on a dog-like robot developed by Boston Dynamics, the researchers have shown that they can measure skin temperature, breathing rate, pulse rate, and blood oxygen saturation in healthy patients, from a distance of 2 meters. They are now making plans to test it in patients with Covid-19 symptoms.

“We are thrilled to have forged this industry-academia partnership in which scientists with engineering and robotics expertise worked with clinical teams at the hospital to bring sophisticated technologies to the bedside,” says Giovanni Traverso, an MIT assistant professor of mechanical engineering, a gastroenterologist at Brigham and Women’s Hospital, and the senior author of the study.

The researchers have posted a paper on their system on the preprint server techRxiv, and have submitted it to a peer-reviewed journal. Huang is one of the lead authors of the study, along with Peter Chai, an assistant professor of emergency medicine at Brigham and Women’s Hospital, and Claas Ehmke, a visiting scholar from ETH Zurich.

Measuring vital signs

When Covid-19 cases began surging in Boston in March, many hospitals, including Brigham and Women’s, set up triage tents outside their emergency departments to evaluate people with Covid-19 symptoms. One major component of this initial evaluation is measuring vital signs, including body temperature.

The MIT and BWH researchers came up with the idea to use robotics to enable contactless monitoring of vital signs, to allow health care workers to minimize their exposure to potentially infectious patients. They decided to use existing computer vision technologies that can measure temperature, breathing rate, pulse, and blood oxygen saturation, and worked to make them mobile.

To achieve that, they used a robot known as Spot, which can walk on four legs, similarly to a dog. Health care workers can maneuver the robot to wherever patients are sitting, using a handheld controller. The researchers mounted four different cameras onto the robot — an infrared camera plus three monochrome cameras that filter different wavelengths of light.

The researchers developed algorithms that allow them to use the infrared camera to measure both elevated skin temperature and breathing rate. For body temperature, the camera measures skin temperature on the face, and the algorithm correlates that temperature with core body temperature. The algorithm also takes into account the ambient temperature and the distance between the camera and the patient, so that measurements can be taken from different distances, under different weather conditions, and still be accurate.

Measurements from the infrared camera can also be used to calculate the patient’s breathing rate. As the patient breathes in and out, wearing a mask, their breath changes the temperature of the mask. Measuring this temperature change allows the researchers to calculate how rapidly the patient is breathing.

The three monochrome cameras each filter a different wavelength of light — 670, 810, and 880 nanometers. These wavelengths allow the researchers to measure the slight color changes that result when hemoglobin in blood cells binds to oxygen and flows through blood vessels. The researchers’ algorithm uses these measurements to calculate both pulse rate and blood oxygen saturation.

“We didn’t really develop new technology to do the measurements,” Huang says. “What we did is integrate them together very specifically for the Covid application, to analyze different vital signs at the same time.”

Continuous monitoring

In this study, the researchers performed the measurements on healthy volunteers, and they are now making plans to test their robotic approach in people who are showing symptoms of Covid-19, in a hospital emergency department.

While in the near term, the researchers plan to focus on triage applications, in the longer term, they envision that the robots could be deployed in patients’ hospital rooms. This would allow the robots to continuously monitor patients and also allow doctors to check on them, via tablet, without having to enter the room. Both applications would require approval from the U.S. Food and Drug Administration.

The research was funded by the MIT Department of Mechanical Engineering and the Karl van Tassel (1925) Career Development Professorship.

Originally published by

August 31, 2020
MIT News
 
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