A team of researchers from the West Virginia University (WVU) Rockefeller Neuroscience Institute (RNI), along with WVU’s Medicine department and staff from Oura Health have developed a platform they say can be used to anticipate the onset of COVID-19 symptoms in otherwise healthy people up to three days in advance. This can help with screening of pre-symptomatic individuals, the researchers suggest, enabling earlier testing and potentially reducing the exposure risk among frontline healthcare and essential workers.
The sudsy involved using biometric data gathered by the Oura Ring, a consumer wearable that looks like a normal metallic ring, but that includes sensors to monitor a number of physiological metrics, including body temperature, sleep patterns, activity, heart rate and more. RNI and WVU Medical researchers combined this data with physiological, cognitive and behaviroral biometric info from around 600 healthcare workers and first responders.
Participants in the study wore the Oura Ring, and provided additional data that was then used to develop AI-based models to anticipate the onset of symptoms before they physically manifested. While these are early results from a phase one study, and yet to be peer-reviewed, the researchers say that their results showed a 90 percent accuracy rate on predicting the occurrence of symptoms including fever, coughing, difficulty breathing, fatigue and more, all of which could indicate that someone has contracted COVID-19. While that doesn’t mean that individuals have the disease, a flag from the platform could mean they seek testing up to three days before symptoms appear, which in turn would mean three fewer days potentially exposing others around them to infection.
Next up, the study hopes to expand to cover as many as 10,000 participants across a number of different institutions in multiple states, with other academic partners on board to support the expansion. The study was fully funded by the RNI and their supporters, with Oura joining strictly in a facilitating capacity and to assist with hardware for deployment.
Many projects have been undertaken to see whether predictive models could help anticipate COVID-19 onset prior to the expression of symptoms, or in individuals who present as mostly or entirely asymptomatic based on general observation. This early result from RNI suggests that it is indeed possible, and that hardware already available to the general public could play an important role in making it possible.
The ongoing COVID-19 pandemic is resulting in big shifts across industries, but the development of more long-term solutions that address a future in which what we need to do is mitigate the impact of the new coronavirus seems like a worthwhile place to invest time and effort. Projects like a new one from Northwestern University researchers working with the Shirley Ryan AbilityLab in Chicago that resulted in a wearable to potentially provide early warnings to COVID-19 patients are a prime example of that kind of work.
The wearable is designed to be worn on the throat, and it’s already in use by around 25 individuals, who are providing early data about its effectiveness via at-home and in-clinic monitoring. The hardware involved monitors coughs and respiratory activity, and then feeds that into a set of algorithms developed by the research team that can identify what might be early symptoms of COVID-19, and potential signs that the infection is progressing in a dangerous way that could require more advanced care.
The gadget is designed to be worn around the clock, and provides a continuous data stream. This has the advantage of providing insight as it becomes available, instantly, instead of relying on regular check-ins, or waiting for when symptoms are clearly bad enough that someone needs additional help, at which point it’s usually past the stage of early intervention. The wearable essentially looks like a thin bandage the size of a postage stamp, and it can monitor not only cough sounds and frequency, but also chest movements, heart rate, body temperature and respiratory rate.
It’s tuned specifically to what health experts have generally tagged as the most common early symptoms of COVID-19, which include fever, coughing and problem breathing. The “suprasternal notch,” which is the technical name for the site on the throat where the wearable rests, is “where airflow occurs near the surface of the skin” through the respiratory pathways of the body, according to Northwestern researcher John A. Rogers who led the device’s development team.
This hardware can potentially be useful in a number of ways: First, it’s a valuable tool for front-line healthcare workers, offering them what will hopefully be an early warning sign of any oncoming illness, so they can avoid infecting their colleagues and get the treatment they need as efficiently as possible. Second, it could be used by those already diagnosed with COVID-19, to potentially provide valuable insight into the course of the infection, and when it might be getting worse. Third, it could eventually also be used to tell scientists working on therapies what is working, how and how well, with live information from test subjects both in-clinic and at home.
The device is also relatively easy to produce, with the team saying they can do so at a rate of around hundreds per week, without even needing to lean very heavily on outside suppliers. That’s a considerable advantage for any hardware that might need to be leveraged in volume to address the crisis. Plus, people can wear it almost unnoticed, and it’s very easy to use both for clinicians and patients.
There are other projects in the works to see how devices that monitor biometrics, including the Oura ring, and the Kinsa thermometer, can help contain the epidemic. The researchers behind this wearable have spun up an engineering company called Sonica to manage their device’s development, and will now be working with various agencies (including through funding by BARDA) to deploy it in more places, and see about potentially productizing the wearable for wide-scale use.
LabCorp’s at-home COVID-19 test, which is called ‘Pixel,’ has received the first Emergency Use Authorization (EUA) for such a test missed by the U.S. Food and Drug Administration (FDA). The test is an at-home collection kit, which provides sample collection materials including a nasal swab to the user, who then uses the included shipping package to return the sample to a lab for testing.
Until now, the FDA has not authorized any at-home testing or sample collection kits for use, and in fact clarified its guidelines to specifically note that their use was not authorized under its guidelines when a number of startup companies debuted similar products for at-home collection and round-trip testing with labs already certified to run molecular RT-PCR tests to detect the presence of COVID-19.
The FDA notes that only LabCorp’s COVID-19 RT-PCR test has received this authorization, and that it still requires any such test to have an EUA before they can being offering services, whether or not the test is administered at home with the help of guidance from an authorized medical professional via telemedicine. Some labs facilitating at home serology tests using an exception in the FDA guidelines, but these are not viewed by the agency as tests that can confirm a case of COVID-19.
Opening up at-home testing (even via just sample collection, vs. full at-home test administration) is a big step in terms of a change in the way the agency has operated thus far. The FDA has recently updated its guidelines to note that it is working with at-home test providers to determine the best way to make those available to the public, since it “sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection.”
LabCorp is a U.S. medical diagnostics company with over 40 years of experience, including at-home testing via its Pixel line for colorectal cancer, diabetes, and cardiac lipid conditions. It seems like the FDA is favoring long-standing industry experience in terms of who it’s willing to open up authorizations for with at-home collection, which is likely due to the potential for increased error when you add unsupervised self-collection, packing and logistics into the mix.
Testing for COVID-19 in the U.S. currently relies on drive-through sites, as well as in-clinic and hospital testing. These tests have a high bar for access in terms of risk profile and symptom presentation, and their administration also exposes the healthcare professionals running them to risk of contracting the infection themselves. At-home testing could increase overall testing rates, while decreasing risk to frontline healthcare workers, providing a better picture of the true extent and depth of the COVID-19 pandemic.
A lot of startups have answered the call for more personal protective equipment (PPE) and other essentials to support healthcare workers in their efforts to curb the spread and impact of COVID-19. One of those is direct-to-consumer 3D-printed eyewear brand Fitz, which is employing its custom-fit glasses technology to build protective, prescription specs to frontline healthcare workers in need of the best protection they can get.
Fitz Protect is a version of Fitz’s eyesore that uses the same custom measurement tool Fitz created for use via its iOS app, made possible by Apple’s depth-sensing Face ID camera on newer iPhones and all iPad Pro models. The app allows virtual try-on, and provides millimeter-level accurate measurements for a custom fit. Protect is a version of the glasses that still supports a wide range of prescriptions, but that also extends further like safety glasses to provide more coverage and guard against errant entry of any fluids through the eyes.
Health care professionals are doing what they can to ensure their face, mouth, nose and eyes are protected from any coughs, sneezes or other droplet-spreading activity from COVID-19 patients that could pass on the infection. These measures have more broadly focused on face shields that feature a single transparent plastic sheet, and N95 masks (and alternatives when not available) to protect the mouth and nose.
Fitz CEO Gabriel Schlumberger explained via email that the design for Fitz Protect came from working frontline doctors in nurses from New York, LA and Texas who were all looking for something to source prescription protective eyewear.
“More than 60% of doctors are glasses wearers, and current guidance is for them to stop wearing contact lenses,” Schlumberger explained, adding that Fitz Protect is also designed to be worn in conjunction with a face shield, when that’s an available option, and provide yet another layer of defense.
“We heard from prescription glasses wearers that their standard glasses didn’t provide anywhere near adequate coverage, especially over the eyebrows, and in some cases they were adding cardboard cut-outs,” he said. “We leveraged our existing system to create something much better. ”
Fitz’s model also helps on the pricing side because it’s already designed to be an aggressively cost-competitive offering when compared to traditional prescription eyesore. Their glasses typically retail for just $95 including frames, lenses and shipping, and are also offered in a $185 per year unlimited frame membership plan. For doctors, nurses and hospital staff, the entire cost of Fitz Protect is being waived, and the company is seeking donations to help offset its own manufacturing costs, which currently stand at around $100 per set, though process improvements should bring that down according to Schlumberger as they expand availability.
Already, he said that nearly 3,000 healthcare professionals have signed up to receive a pair in their first week of availability, so they’re working on adding scale to keep up with the unexpected demand.
A new study conducted by the University of Southern California along with the LA County Department of Public Health indicates that the presence of antibodies for COVID-19 in between 2.5 and 5.6% of the population of LA County, suggesting that between 221,000 and 442,000 individuals had the infection – up to 55 times more people than have been confirmed via testing. This is the second antibody study in a short span of time in California that suspects infections are far more widespread than previously thought, and a good justification for continued social distancing measures.
The LA County study does contain some good news, if the antibody testing proves to be accurate (we aren’t entirely sure what they show for sure at this point, especially in terms of immunity), in that the mortality rate of the infection is actually much lower than the official diagnosed case data would suggest. The infection rate found via antibody testing through the USC study is also remarkably close to the rate found in a Stanford study published last week about the number of infections in Santa Clara County, which found that between 48,000 and 81,000 people in that part of California could’ve had and recovered from the infection.
Whereas the LA study found around 2.8 to 5.6 parent had antibodies, accounting for the margin of error and extrapolating from results to the entire population, the Stanford research found between 2.5 and 4.2 percent of residents carry antibodies for the infection. Those numbers are based on the test kits’ performance, as well as the demographic makeup of the sample population tested.
Neither new research papers have yet been peer-reviewed, so it’s worth taking them with a grain of salt. But the close alignment between the numbers in both, along with early results from similar studies being conducted globally, does seem to suggest that the number of actual cases of COVID-19 far undershoots the published numbers, which typically only include confirmed diagnoses – most of which represent individuals showing moderate to severe symptoms.
The higher rate of undetected infection definitely should not be taken as a sign that COVID-19 is less serious than it appeared, however; this new info only means that its transmission from people who showed no outward symptoms and never subsequently never sought any medical care or were identified for quarantine or contact tracing is probably a lot higher than anyone guessed.
That means social distancing measures are more important than ever, since it’s likely harder than ever to identify who might be a passive carrier of the virus that leads to COVID-19 without realizing it. Eventually, understanding the nature of the spread should help with refining measures to avoid the greatest potential risks of exposure, but for now, this new info just means that COVID-19 is much more effective at moving through a population without raising early warning signs than we previously understood.
The diagnostics startup Curative has received an emergency use authorization from the Food and Drug Administration for its novel test to determine COVID-19 infection.
The company says that its tests have already been used by the City of Los Angeles since late March and have tested over 53,000 city residents.
Curative’s tests use an oral-fluid sample collected by having the subject cough to produce sputum, which release the virus from deep in the lungs, according to a spokesperson.
Here’s how the letter digitally signed by the FDA’s chief science officer, Denise Hinton, describes the Rucative test:
To use your product, SARS-CoV-2 nucleic acid is first extracted, isolated and purified from oropharyngeal (throat) swab, nasopharyngeal swab, nasal swab, and oral fluid specimens. The purified nucleic acid is then reverse transcribed into cDNA followed by PCR amplification and detection using an authorized real-time (RT) PCR instrument. The Curative-Korva SARS-Cov-2 Assay uses all commercially sourced materials or other authorized materials and authorized ancillary reagents commonly used in clinical laboratories as described in the authorized procedures submitted as part of the EUA request.
Curative, which was first covered by DotLA, is processing the tests in conjunction with Korva Labs, a testing facility associated with UCLA.
These tests hope to get around the supply chain shortages that constrain the number of tests the US can conduct. Currently, the US is still experiencing a shortage of test kits because the supply chain for critical components used in test kits has been disrupted by the global COVID-19 pandemic, the company said.
Curative is working to build alternatives to many of the sample collection and extraction kit components and what it calls more scalable RNA extraction methods that don’t rely on the use of magnetic silica beads.
The company was initially founded in January 2020 to focus on a novel test for sepsis, but pivoted to focus on COVID-19 testing as the disease swept across the globe.
“Our goal is to assemble an orthogonal supply chain to supply coronavirus test kits. Doing so will help us avoid buying materials that would constrain public health and CDC laboratories from ramping up production,” the company said on its website. “We are also working to partner with other operations looking to spin up testing facilities to help them source necessary reagents.”
Curative says that its test is better for two reasons. Its sampling method reduces the risk of exposure for healthcare workers and requires less Personal Protective Equipment and its use of an alternative supply chain means it can scale tests rapidly.
The company can already process roughly 5,000 tests per day and is manufacturing 20,000 test kits over the same period. Test results can be delivered in around 31 hours.
“Broad access to testing is critical to our nation’s response to COVID-19 and with this authorization, we can continue scaling and distributing our test nationwide,” said Fred Turner, the chief executive and founder of Curative Inc. “Our work with the Cities of Los Angeles and Long Beach has helped thousands of people access testing at drive-through facilities and we are fully equipped to expand that access to help thousands more across the country. At the same time, we are continuing to work with the FDA to validate our test for at-home collection, which would expand access even more.”
With the new authorization, the company is going to begin working with additional distributors around the country.
The Curative tests are already used by Los Angeles, Long Beach and through testing organized by LA County and the LA County Fire and Sherrif’s Department. The tests aren’t being sold directly to consumers and must be ordered by a physician, the company said.
Backed by the venture firm DCVC, Curative has already been the subject of some controversy when its investor sent a letter to limited partners indicating they’d be able to get access to the Curative tests upon request.
The firm wrote:
“… please let us know as soon as possible if you are experiencing COVID-19 symptoms and are unable to get tested. Through a unique relationship with one of our portfolio companies, we will expedite delivery of a test kit (simple, fast, safe saliva/cheek swab) that should provide results within 1-3 days via return by mail.”
In a subsequent blog post, the partners at DCVC explained their outreach.
With changes in regulations enabling telemedicine across state lines, we wanted to make sure everyone DCVC knows was aware of Carbon’s excellent care and full suite of testing. And yes, that includes people who work at our Limited Partners, who are making difficult decisions for themselves and their families in difficult times like the rest of us.
With Carbon moving at the pace they do with their fast, friendly electronic on-boarding, and with Curative’s testing capability likely ramping to 10,000+ tests a day in the next ten days, the combined health care firepower can indeed “expedite” care for everybody.
Was our language a little boastful? Yes, no excuses. And we’re sorry if folks got the wrong idea. No one is “jumping in line.” We will always strive to point out to our friends and community where they can get quick access to quality care as well as access to other cutting-edge technology in our portfolio.
Accurate testing remains the most important feature of any effort to contain the COVID-19 outbreak and a number of startup companies are working on novel diagnostics.
As Harvard University epidemiologist, William Hanage told Business Insider, “Figuring out what’s actually going on in the community is the key part of dealing with this pandemic.”
One of the largest COVID-19 vaccine trials currently underway will have over 500 volunteers actively testing its solution by the middle of next month. Researchers at the University of Oxford have already secured that number of participants, including a representative sample of people between the ages of 18 to 55, for a large-scale randomized clinical early and mid-stage trial of its potential vaccine, which uses a harmless, modified virus to trigger an immune response that is also effective against the novel coronavirus.
The trial will divide a total of 510 participant sent five groups, with one group receiving a follow-up, booster shot of the vaccine after the original does. The technology behind the vaccine has already been used in developing about 10 different other treatments, but will require an approach that includes setting up different test groups in different countries to ensure representative results, since infection rates are varying greatly place to place with prevention measures in place, study lead Sarah Gilbert told Bloomberg.
The team behind the vaccine is also still seeking additional funding to help scale manufacturing, since it aims to begin producing it in volume following the six month period this human trial phase will span. The goal is to have mass production up and running by this fall, under the assumption that the trial proves the potential vaccine effective, with a final stage trial of 5,000 people and the potential to begin providing some doses for use by frontline healthcare workers by as early as September.
The Oxford trial is one of just a handful that have progressed to the human testing phase, but more are coming online all the time. Existing clinical human trials from Moderna and Inovio are underway in the U.S., and those have also expressed the potential for earlier access for emergency use prior to broad rollout following the initial clinical results.
Even if there is some availability by fall of some of these vaccine candidates (and that assumes they even prove effective), that doesn’t mean they’ll be broadly available: That will still require further testing, and scaling manufacturing, as well as working out distribution and administration – all processes that will add months of work. Already, however, the unprecedented nature of the COVID-19 pandemic has resulted in new efficiencies in the development process, and more could follow in these extraordinary times.
Celularity, the venture-backed developer of novel cell therapies for cancer treatments, has received an initial clearance from the Food and Drug Administration to begin early-stage clinical trials on a potential treatment for COVID-19.
The company, which has raised at least $290 million to date (according to Crunchbase), uses “Natural Killer” (NK) cell therapies to boost the immune system’s disease-fighting response.
For Celularity, those NK cells are derived from stem cells cultivated from placental tissue, which hospitals typically treat as medical waste.
Backed by the venture investment firm Section 32, and strategic investors including Celgene, now a division of Bristol Myers; United Therapeutics, a biomedical technology developer; Human Longevity, the troubled venture-backed startup founded by J. Craig Venter; and Sorrento Therapeutics, a publicly traded biomedical company, Celularity was pursuing a number of applications of the novel cell therapy, but its initial focus was on cancer treatments.
The real breakthrough for the company, and one of the reasons it has attracted so much capital, is that its cell therapies don’t need to be cultivated from a patient donor — a lengthy and expensive process. Celularity is able to produce NK cells and store them, so that they can be ready for transfusion when they’re needed.
With the the FDA’s clearance, Celularity is going to begin a small, 86-person trial to test the efficacy of its CYNK-001 immunotherapy to treat COVID-19 infected adults, the company said.
There are at least two studies underway in China that are also testing whether Natural Killer cells can be used to treat COVID-19.
NK cells are a type of white blood cell that are part of the body’s immune system. Unlike t-cells, which target particular pathogens, NK cells typically work to support the immune system by identifying and destroying cells in the body that appear to be stressed, either from an infection or a mutation.
The therapy seems to be successful in treating certain types of cancer, and the company’s researchers speculate that it can provide similar results in stopping the ability of the novel coronavirus, which causes COVID-19 to spread throughout the body.
However, there are some potential roadblocks and risks to pursuing the NK therapy. Chiefly, COVID-19 is deadly in part because it can push the immune system into overdrive. The “cytokine storm” that results from the infection means that the body starts attacking healthy cells in the lungs, which leads to organ failure and death. If that’s the case, then boosting the immune response to COVID-19 might be dangerous for patients.
There’s also the possibility that NK cells might not be able to detect which cells are infected with the coronavirus which causes COVID-19, rendering the therapy ineffective.
“Studies have established that there is robust activation of NK cells during viral infection regardless of the virus class,” said Celularity’s chief scientific officer, Xiaokui Zhang, in a statement. “These functions suggest that CYNK-001 could provide a benefit to COVID-19 patients in terms of limiting SARS-CoV-2 replication and disease progression by eliminating the infected cells.”
On Thursday, the FDA amended their emergency policy around diagnostic testing for SARS-CoV-2, the novel coronavirus that causes COVID-19. Following on a change made March 16, the agency opened the door for a number of specific private entities and labs to develop and distribute tests that can provide results on the spot in as little as 15 minutes – but there are some pretty big caveats to keep in mind as you hear about more of these coming to market.
The tests, which are ‘serological,’ meaning they identify the presence of antibodies in a person’s blood, differ considerably from the molecular testing that is currently in use under Emergency Use Authorization (EUA) by FDA-approved labs and drive-through testing sites. The serological tests show that a person has developed antibodies to SARS-CoV-2, which means they very likely came into contact with it (and either have it, or have already recovered from having it). The molecular tests actually detect the presence of viral DNA in the blood stream, which is a much more definitive indicator that they currently have an active infection (at least at the time the swab was taken).
Serological tests have still been used widely in countries where the response to the COVID-19 pandemic has been shown to be effective, including in China, Taiwan and Singapore. They’ve also been used in different communities in the U.S., based on earlier guidelines around private lab diagnostics, but on March 26 the FDA named 29 entities who had provided notification to the agency as required and are now therefore able to distribute their tests.
It’s important to note that these tests have not been reviewed or validated by the FDA, unlike those molecular tests that are included in the organizations emergency use category. Instead, the FDA “does not intend to object to the development and distribution by commercial manufacturers” of these tests, provided they meet a number of criteria, including qualifying the results of their reported test results with the following information:
- This test has not been reviewed by the FDA.
- Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
- Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
The FDA specifically notes in its emergency use FAQ that these entities have reported their own validation of these tests, and that they won’t be pursuing Emergency Use Authorization. That said, there’s now nothing stopping the entities on this list from distributing their tests, which means they will be able to be put to use in testing Americans and painting a larger picture of the potential spread of the novel coronavirus – with the caveat noted above that the FDA doesn’t consider these tests used alone to be positive confirmation of a definite SARS-CoV-2 case, or conversely, a sure indicator that someone doesn’t have the virus.
Still, in the absence of better options like expanded available of the tests that are approved under the EUA, these serological tests (many of which can provide on-site results with just a pinprick of blood) will be useful in painting a more accurate picture of the overall spread and reach of the coronavirus, especially for smaller clinics, GP clinics and local labs that don’t have priority access to the equipment and supplies needed for the molecular testing efforts.
For instance, ne test on this list, the Healgen Scientific COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device, requires no instrumentation and can provide results in just 15 minutes. Distributor Ideal Rehab Care is working with its legal representation Fox Rothschild to begin importing the tests from Singapore for use “as soon as possible.”
The FDA updating its website with Healgen as one of the entities that have notified it of intent to use its serological test is what unlocked the ability for the company to begin distribution: It’s still illegal for anyone not on this list to do so, and the FDA still also specifically prohibits the use of at-home serological tests on its official guidelines.
There are a growing number of symptom checker and screening tools that you can use at home if you suspect you might have contracted the new coronavirus that is causing the global COVID-19 pandemic. Most of these are relatively simple, including around three or four questions that basically cover the top reported symptoms experienced by anyone who has confirmed to have had the disease. Chatbot-based symptom checking software startup Clearstep has created its own COVID-19 screener, which goes more in-depth to combine symptom checking with screening for potential exposure to the virus.
The reason Clearstep’s tool is designed to go a step further than most is simple, according to co-founder and COO Bilal Naved – the symptoms reportedly suffered by those affected by COVID-19 include many that could indicate other serious conditions, including an impending heart attack. More effective and comprehensive screening can also help reduce the burden on an already heavily-taxed healthcare system, which seems likely to only get busier over time as the number of cases across the U.S. continues to climb.
Naved and cofounder Adeel Malik, both of whom have worked in health at Johns Hopkins University and been involved in a number of academic scientific publications, developed Clearstep as a front-line way to connect patients with the right care, using remote screening facilitated via chatbot on their desktop or mobile device. Clearstep’s aim fits naturally with one of the key needs in the ongoing coronavirus pandemic – effective screening that can provide individuals with clear and accurate guidance about what steps they need to take to seek care, and when.
“Our country is entering a time of a lot of uncertainty, but but also a time where there could be a true, critical threat to the integrity of the healthcare system,” Naved said in an interview. “If the rate of infection of this really reaches some projections, we might not have enough hospital beds or ICU beds to deal with all of this […] So it’s all about urgency and speed here and rapid response, but also being able to deliver the highest quality product. We are built off of nurse protocols, and we’re the only ones that have access to this in a publicly available chatbot format that has been used in over 200 million encounters in over 95% of the call centers around the country.”
Clearstep’s screener asks a range of questions about symptoms, travel, potential contact with anyone either diagnosed with COVID-19 or likely to have it based on their own travel and other factors. Once you go through the questions, which are presented in a fairly standard and easy-to-follow chat message format, the tool provides you an evaluation of what next steps you should take. It’ll provide you advice about whether or not you need testing for COVID-19 based on current CDC guidelines about who should be tested – and alert you about whether you should seek care for any other reason, independent of your potential coronavirus exposure.
The Clearstep team is also making sure to stay on top of new research as it emerges regarding the presentation and likelihood of symptoms in COVID-19 patients. Their approach focuses on data-driven representation of the symptoms that most people are likely to have, and then also taking the less likely presenting symptoms and building a model wherein those compound and add up to a total. The team is “keeping a pulse in the literature” published in peer-reviewed sources and adapting its screener as it needs to, as well, Naved says.
Ultimately, Naved thinks that where Clearstep can contribute is in its ability to integrate quickly with healthcare providers, providing a triage tool that can give frontline responders a way to interface with the public safely, while also helping to ensure that all the health issues that are not related to COVID-19 but that are still serious and require care don’t get left behind.
“We were able to go from first conversation to contract signed to configured and implemented in total of nine days,” Naved says about their speed of response. “The contracts took six days and in three days, we we customized, put in behind their branding, integrate itd and deployed it out to an entire population in Florida for a health system there […] The symptom checkers that are being put out there need to be able to integrate with those places that are seeing the massive influx of volume and may not be able to handle it, because that’s our responsibility right now.”
Medical biotech company Emergent BioSolutions is one of the many health industry players turning its efforts toward addressing the current global coronavirus pandemic. Their work includes a two-pronged effort to pursue plasma-based treatments that could help lessen the impact of COVID-19 on healthcare systems, with a fast-tracked development timeline that could see human clinical trials start as soon as this summer.
The company is simultaneously working on two different therapeutic approaches, including one that uses plasma (a liquid that is the majority component of blood) sourced from humans, and one that sources it from horses. Both involve development of antibodies consisting of different immune cells that all target the SARS-CoV-2 virus, which work by boosting the body’s existing immune response in patients to fight off infection. The treatment based on human plasma would be suitable for use for patients who are hospitalized and showing severe symptoms, and also potentially for providing some measure of protection for at-risk people, including front-line healthcare workers, while the horse-derived version would be aimed specifically at addressing those severe hospitalized cases.
Plasma-based treatments (which involve purifying out the antibodies and concentrating the dose) are not new, and both of these therapies in development will leverage technologies, manufacturing processes and other infrastructure that Emergent BioSolutions has used in developing other FDA-approved plasma-based treatments for different diseases. That’s what’s helping it fast-track its work on solutions to address COVID-19, which could bridge the gap between where we are now and the year or more it will take to develop an effective vaccine.
“We looked at where we are in our platforms, and our ability to take some of our proven technologies and apply it to COVID-19,” explained Dr. Laura Saward, head of Emergent BioSolution’s Therapeutics Business Unit. “On the therapeutic side, there were two areas we were really focused on. I think the opportunity to provide a therapy that would be a rescue therapy for patients in hospital, who are suffering from severe disease is definitely a need today, as well as the ability to go in and prevent people at risk from developing more severe disease.”
The goal, with both approaches, Dr. Saward said, is to attempt to reduce the burden suffered by the healthcare system, freeing up its resources to better address the coronavirus crisis. That’s a similar end to the strategy of encouraging individuals to distance themselves physically from one another — health officials are hoping that, if these rules are properly observed, individuals can avoid being infected all at once and overwhelming the hospital system.
Therapeutics used in treatment of cases could be another key ingredient in a larger plan designed to mitigate the most dire projected effects of a global coronavirus pandemic. Especially when, as is the case with the treatments that Emergent BioSolutions is developing, there is already infrastructure in place that can help speed the development of these therapeutics.
“We have two platforms that we looked at, within the antibody therapeutics space, really looking at our existing infrastructure, and the manufacturing processes that we have as part of our overall platform for this approach,” Dr. Saward said. “You know, in the, in this situation, when we looked at these two platforms, they supported several FDA-licensed drugs, which, while it doesn’t give us the benefit of having some sense of dosing safety, we can certainly use that manufacturing process in a way where we’ve got our our common elements for manufacturing and controls and would help to support an FDA application.”
There has been plenty said about efforts by the FDA and other global health agencies to cut through red tape and speed the approval process around COVID-19. That includes everything from tests to treatments and vaccines. I asked Dr. Saward what’s actually involved in fast-tracking something as sensitive and safety focused as approval for new therapeutics.
“We’ve always worked very closely with the regulators in understanding sort of what parts of those packages are common to our process,” she said. “As we bring a new drug through, we’re often able to leverage many of the same elements around the safety profile, the PK profile [basically how fast a drug is absorbed, metabolized, excreted, etc.] for the products, the manufacturing controls and assays that are validated — that’s all common. What we’re changing, really, is just at the front end: The plasma that’s going into that process will be specific to the COVID antibodies in this case.”
This ensures that while they can still ensure safety, they don’t need to do re-work that would otherwise be time-consuming for processes into which the FDA already has full visibility. Time and effort can focus on the stages of the drug development that are new, instead of on what’s repeated.
Thanks to its ability to leverage past work, Emergent BioSolutions is now working with a time frame that includes entering manufacturing by this summer, and then having products available in test clinics by end of summer. If all goes to plan, that means kicking off Phase Two testing in human patients by around late summer or early fall.
That may seem a long way off, but it’s actually a speedy timeline by therapeutics development standards. Saward says that she’s seen the FDA evolve their thinking on data collection and dynamism in light of technological advancement, which has helped their collaboration with industry in getting needed treatments to market. In the meantime, that still means individuals need to do their part to provide Emergent and others working on these solutions the time they need for proper development and testing, through actions like physical distancing and self-isolation.
Earlier this week, the U.S. Food and Drug Administration (FDA) announced that it would be updating its guidance to allow self-swab tests for COVID-19, in which a patient collects a sample from their own nose for a health professional to test. On Wednesday, UnitedHealth Group revealed the results of a peer-reviewed large-scale study that provided the science behind the decision to switch to the less-invasive sample collection method.
The self-swab process doesn’t change where FDA-approved testing can happen — this expanded guidance only applies to the method of collection, meaning at-home swab-based PCR tests that many startups had hoped to bring to market are still on hold. But even though people still have to go to either clinics or drive-through testing sites to get a COVID-19 test done, the ability to self-swab offers more comfort, as well as real advantages when it comes to the health and safety of the clinicians and front-line healthcare workers staffing the sites.
This new study shows that not only does self-swabbing lessen the chance of someone with COVID-19 passing on their infection to a healthcare worker, it’s also just as effective as a test where clinicians collected the sample from much deeper inside a person’s nasal cavity. UnitedHeatlh worked with the Bill & Melinda Gates Foundation, as well as Quest Diagnostics and the University of Washington to conduct the study, which covered almost 500 patients who received tests at OptumCare diagnostic facilities in the state of Washington.
There are other benefits to the self-swab method as well, including eliminating the need for specifically trained medical professionals who have to administer the tests at point-of-care. This should help with clearing up backlogs owing to staffing, at least, though supplies and bottlenecks due to demand are going to persist as more people seek diagnosis.
Three years ago, the U.K. government chastised WhatsApp for enabling end-to-end encryption by default. Today, it’s relying on the encrypted messaging app as a vital service for sharing information about the coronavirus pandemic.
The new chatbot, supplied by the U.K. government, will let anyone subscribe to official advice about the pandemic, known as COVID-19, in the hope of reducing the burden on its national health system.
Send “hi” to 07860 064422 (or +44 7860 064422 for international users) over WhatsApp to start receiving updates.
The U.K. government’s official WhatsApp account, which it’s using to share information about the coronavirus pandemic (Image: TechCrunch)
The U.K. government said the service will also allow the government to send messages to all opted-in users if required.
Currently the U.K. does not have a national emergency alert system, unlike the U.S., to notify citizens en masse about incidents or emergencies. South Korea was praised for its use of sending up-to-date emergency alerts to citizens, which experts say has helped “flatten the curve” of infections, a reference to slowing the rate of infection to help ease the burdens on hospitals.
British Prime Minister Boris Johnson declared a national lockdown on Tuesday, ordering all non-essential citizens and residents to stay at home in an effort to fight the spread of the pandemic.
U.K. authorities had faced criticism for failing to issue the stay-at-home order sooner. Several other countries and cities with spiking infection rates, including Italy and New York, had ordered their citizens to remain at home.
As of Wednesday, there were more than 438,000 confirmed global cases of COVID-19, with 19,000 deaths recorded.