99.992% of fully vaccinated people have dodged COVID, CDC data shows

Residents wait in an observation area after receiving Covid-19 vaccines at a vaccination site in Richmond, California on Thursday, April 15, 2021.

Enlarge / Residents wait in an observation area after receiving Covid-19 vaccines at a vaccination site in Richmond, California on Thursday, April 15, 2021. (credit: Getty | Bloomberg)

Cases of COVID-19 are extremely rare among people who are fully vaccinated, according to a new data analysis by the Centers for Disease Control and Prevention.

Among more than 75 million fully vaccinated people in the US, just around 5,800 people reported a “breakthrough” infection, in which they became infected with the pandemic coronavirus despite being fully vaccinated.

The numbers suggest that breakthroughs occur at the teeny rate of less than 0.008 percent of fully vaccinated people—and that over 99.992 percent of those vaccinated have not contracted a SARS-CoV-2 infection.

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#breakthrough, #cdc, #covid-19, #infection, #infectious-disease, #public-health, #sars-cov-2, #science, #vaccines

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How Rani Therapeutics’ robotic pill could change subcutaneous injection treament

A new auto-injecting pill might soon become a replacement for subcutaneous injection treatments.

The idea for this so-called robotic pill came out of a research project around eight years ago from InCube Labs—a life sciences lab operated by Rani Therapeutics Chairman and CEO Mir Imran, who has degrees in electrical and biomedical engineering from Rutgers University. A prominent figure in life sciences innovation, Imran has founded over 20 medical device companies and helped develop the world’s first implantable cardiac defibrillator.

In working on the technology behind San Jose-based Rani Therapeutics, Imran and his team wanted to find a way to relieve some of the painful side effects of subcutaneous (or under-the-skin) injections, while also improving the treatment’s efficacy. “The technology itself started with a very simple thesis,” said Imran in an interview. “We thought, why can’t we create a pill that contains a biologic drug that you swallow, and once it gets to the intestine, it transforms itself and delivers a pain-free injection?”

Rani Therapeutics’ approach is based on inherent properties of the gastrointestinal tract. An injecting mechanism in their pill is surrounded by a pH-sensitive coating that dissolves as the capsule moves from a patient’s stomach to the small intestine. This helps ensure that the pill starts injecting the medicine in the right place at the right time. Once there, the reactants mix and produce carbon dioxide, which in turn inflates a small balloon that helps create a pressure difference to help inject the drug-loaded needles into the intestinal wall. “So it’s a really well-timed cascade of events that results in the delivery of this needle,” said Imran.

Despite its somewhat mechanical procedure, the pill itself contains no metal or springs, reducing the chance of an inflammatory response in the body. The needles and other components are instead made of injectable-grade polymers, that Imran said has been used in other medical devices as well. Delivering the injections to the upper part of the small intestine also carries little risk of infection, as the prevalence of stomach acid and bile from the liver prevent bacteria from readily growing there.

One of Imran’s priorities for the pill was to eliminate the painful side effects of subcutaneous injections. “It wouldn’t make sense to replace them with another painful injection,” he said. “But biology was on our side, because your intestines don’t have the kind of pain sensors your skin does.” What’s more, administering the injection into the highly vascularized wall of the small intestine actually allows the treatment to work more efficiently than when applied through subcutaneous injection, which typically deposits the treatment into fatty tissue.

Imran and his team have plans to use the pill for a variety of indications, including the growth hormone disorder acromegaly, diabetes, and osteoporosis. In January 2020, their acromegaly treatment, Octreotide, demonstrated both safety and sustained bioavailability in primary clinical trials. They hope to pursue future clinical trials for other indications, but chose to prioritize acromegaly initially because of its well-established treatment drug but “very painful injection,” Imran said.

At the end of last year, Rani Therapeutics raised $69 million in new funding to help further develop and test their platform. “This will finance us for the next several years,” said Imran. “Our approach to the business is to make the technology very robust and manufacturable.”

#biotech, #diabetes, #health, #infection, #medical-devices, #pain, #recent-funding, #robotics, #rutgers-university, #san-jose, #science, #startups, #therapeutics

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Doctors still evasive on Trump’s health as he leaves hospital

A masked man waves through a bulletproof window.

Enlarge / A car with US President Trump drives past supporters in a motorcade outside of Walter Reed Medical Center in Bethesda, Maryland on October 4, 2020. (credit: Getty | Alex Edelman)

After being hospitalized several days for a coronavirus infection and receiving two experimental treatments, supplemental oxygen, and a steroid drug used only for the most severe COVID-19 cases, President Donald Trump on Monday tweeted that he would be leaving Walter Reed National Military Medical Center and returning to the White House.

In a press briefing Monday afternoon, White House physician Sean Conley readily acknowledged that Trump has not yet reached a critical period of his infection—roughly, days seven to 10 after symptoms—in which COVID-19 patients’ conditions can quickly and dramatically deteriorate from overzealous immune responses. Trump is believed to be at around day six of his symptomatic infection.

“Though he may not entirely be out of the woods yet,” Trump’s condition has improved and his medical team cleared him to return to the White House, “where he’ll be surrounded by world-class medical care, 24/7,” Conley explained.

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#covid-19, #hospital, #infection, #president, #public-health, #sars-cov-2, #science, #trump

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Moderna’s 30,000-participant Phase 3 COVID-19 vaccine trial kicks off in the U.S.

The largest trial yet for a potential COVID-19 vaccine began on Monday, as drug company Moderna began providing the first of an anticipated 30,000 volunteers with shots of its candidates. This is a blind trial, wherein some participants will get the vaccine and some will get placebos. Each participant will get two does, and researchers will study them to see which group suffers more actual infections as they proceed about their lives as they would normally.

There are more than 70 anticipated trial sites across the U.S. for this study,; and the first to begin vaccinating the volunteer participants is located in Savannah, Georgia. The makeup of the overall group of participants is intended to study not only geographical distribution, covering regions hard-hit by the virus and those with less severe outbreaks, but also to represent a wide sample when it comes to demographics of those participating.

The Moderna trial is begin undertaken in partnership with the U.S. National Institutes of Health (NIH), and represents one of the fastest development cycles of a vaccine ever. Just around two months after work was begun on the Moderna vaccine, it was already begin tested in humans for the first time, and early data from its Phase 1 tests (which were on a much smaller scale) have shown promising indications that it does indeed provide some infection protection – though large scale tests like this 30,000-person strong one are definitely required before anyone can say anything definitive about its efficacy.

In addition to making sure that the vaccine is actually effective as a vaccine, this large-scale test is intended to prove it’s safe to take. Early results indicated some side effects, but again, it’s impossible to say anything definitively about downsides wither until you test at scale.

Other trials are also making quick progress, including one for a vaccine developed by the University of Oxford. Moderna has previously said that experimental versions of the vaccine might be available on an emergency basis for healthcare workers by this fall, if all goes to plan.

#biotech, #coronavirus, #covid-19, #georgia, #health, #infection, #medical-research, #medicine, #moderna, #national-institute-of-health, #savannah, #tc, #united-states, #vaccination, #vaccine, #vaccines

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Hackers use recycled backdoor to keep a hold on hacked e-commerce server

Hackers use recycled backdoor to keep a hold on hacked e-commerce server

Enlarge (credit: Jeremy Brooks / Flickr)

Who needs a better mousetrap when the old one is fine?

That was the approach of hackers who recently compromised a server running open source e-commerce platform Magento. To guard against the possibility of being locked out of the server should the rightful operators ever discover the breach, the attackers left behind a simple but effective script.

To the naked eye, the script was easy to miss amid countless other Magento files. Examining the code inside, however, revealed that it was a backdoor that was activated by sending the server a simple and innocuous-looking Web request. With that, an attacker who otherwise might have been booted out of the server could instantly become a server administrator with unfettered control of the system.

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#backdoors, #biz-it, #hacking, #infection, #magento

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FDA revokes emergency authorization for chloroquine and hydroxychloroquine in COVID-19 treatment

The U.S. Food and Drug Administration (FDA) has revoked an emergency use authorization (EUA) that it previously issued for chloroquine and hydroxychloroquine, two anti-malarial drugs also used in the treatment of chronic rheumatoid arthritis (via Washington Post). These are the drugs that Trump famously touted as effective in COVID-19 treatment, despite major concerns raised with the scientific validity of early medical investigations that showed they were potentially effective agains the infection beyond the ongoing global pandemic.

Subsequent studies showed conflicting results, including when one team of researchers ended elements of its clinical study into the drugs’ use early due to excess fatalities. The FDA had issued its EUA for use of chloroquine and hydroxychloroquine in late March, prompting criticism from many in the medical and pharmaceutical research community since evidence seemed very mixed in terms of its potential efficacy and risks. Then following those deaths in that subsequent clinical study, it issued a statement of precaution regarding the use of the drugs.

The FDA grants EUAs in circumstances where it deems the benefits outweigh the risks of expediting a provisional authorization for the use of therapies and devices that haven’t undergone its full, rigorous approval process for drugs and equipment. The COVID-19 pandemic has resulted in the FDA releasing many more EUAs than is typical, especially as it pertains to testing equipment used for diagnostic of the infection and SARS-CoV-19, its preceding and causal virus.

Trump irresponsibly touted the value of chloroquine and hydroxychloroquine, and later professed to be taking the medicine himself as a precaution he wrongly believed would stave off infection. The drug’s supply subsequently experienced a number of stresses due to increased demand, which had potentially dire consequences for people with a legitimate need for its consumption due to conditions for which it is approved and clinical shown to be effective, including lupus and chronic arthritis.

#chloroquine, #coronavirus, #covid-19, #food-and-drug-administration, #health, #hydroxychloroquine, #infection, #medicine, #tc, #trump, #washington-post

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Apple adds anonymous symptom and health info sharing to its COVID-19 app and website

Apple has updated its own COVID-19 iOS app and website with new features to allow users to anonymously share info including their age, existing health conditions, symptoms, potential exposure risks and the state in which they’re located. This info, which is not associated with any of their personal identifying data in any way according to the company, will be used in an aggregated way to help inform the Centers For Disease Control and Prevention (CDC) and improve the organization’s COVID-19 screening protocol.

The app will also use the aggregated data to assist public health agencies and the CDC in their efforts to help the public with the best available information about potential risk factors around COVID-19, and around what constitutes exposure and exposure risk.

Apple launched its coronavirus screening app and website back in March, providing not only screening tools to help provide users with guidance on whether or not they should seek testing, but also tips on preventative measures including hand-washing and best practices for sanitization.

This app and website should not be confused with Apple and Google’s collaborative COVID-19 Exposure Notification API, which is a developer tool that the two made available to public health agencies and their partners in order to build apps that can provide anonymized, privacy-friendly notifications to users who may have come in contact with someone who has COVID-19 and might’ve been exposed to infection. Apple’s app is an informational resource and screening tool only, though with this most recent update it also becomes a resource for public health agencies and the CDC to better understand the spread of COVID-19 through aggregated, anonymized data collection.

Despite what it may feel like, COVID-19 still hasn’t been around all that long, and it’s still not super well understood by scientists and researchers. Gathering and studying more data and information about affected populations is a key way that the health community can learn more about the novel coronavirus and how best to mitigate the threat it poses.

#anonymity, #apple, #apple-inc, #apps, #articles, #centers-for-disease-control-and-prevention, #companies, #coronavirus, #covid-19, #google, #health, #infection, #tc

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Researchers use biometrics, including data from the Oura Ring, to predict COVID-19 symptoms in advance

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.

#artificial-intelligence, #biometrics, #biotech, #coronavirus, #covid-19, #disease, #fatigue, #fever, #gadgets, #health, #identification, #infection, #neuroscience, #oura, #surveillance, #tc

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Sorrento finds a coronavirus antibody that blocks viral infection 100% in preclinical lab experiments

Therapeutics company Sorrento has made what it believes cold be a breakthrough in potential treatment of SARS-CoV-2, the virus that leads to COVID-19. The company released details its preclinical research on Friday, announcing that it has found an antibody that provides “100% inhibition of SARS-CoV-2 virus infection of healthy cells after four days incubation.” These results are from a preclinical study that still has to undergo peer review, and in an in vitro laboratory study (meaning not in an actual human being) but still a promising development as the company continues to work on production of an antibody “cocktail” that could provide protection against SARS-CoV-2 even in case of mutations in the virus.

Sorrento says that they believe this antibody, which is labelled STI-1499, stood out among billions of candidates it has been screening from its extensive human antibody library for its ability to completely block the interaction of the SARS-CoV-2’s spike protein with a human cell target receptor. That means it prevents the virus from attaching to the host’s healthy cell, which is what leads to incubation and infection.

The nature of the antibody’s efficacy means that Sorrento currently believes it will be the first antibody to be included in the cocktail it is developing, which will be made up of a large number of different antibodies that show efficacy in blocking the attachment of the spike protein, in order to provide multiple avenues of protection that are designed to remain effective even if the virus mutates in transmission from person to person, or within the same individual. One of the big outstanding questions that researchers are working on answering currently is just how mutagenic SARS-CoV-2 actually is, since many coronaviruses like the common cold show a tendency to mutate pretty quickly, rendering long-lasting cures and treatments difficult to develop.

Sorrento’s COVID-SHIELD is meant to address this through a potent mix of different antibodies that provide protection against different strains of the virus, but the company says it will also be pursuing development of the STI-1499 antibody on its own as a dedicated, standalone therapy. The company is already in discussion with regulators about how to expedite development of that potential treatment, and is ramping its production capacity as well with the goal of producing as many as one million doses at the same time it pursues FDA approval for its use.

It’s definitely worth cautioning that no treatment or vaccine is likely to be a ‘magic bullet’ in treating SARS-CoV-2 or COVID-19, but this is still a promising development, and one to watch as it undergoes clinical trials and the therapeutic development and regulatory process.

#biotech, #coronavirus, #covid-19, #fda, #health, #infection, #medicine, #sars-cov-2, #sorrento, #tc, #viruses

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GreenLight Biosciences raises $17m to ramp mRNA production for COVID-19 vaccine candidate trials

One of the approaches therapeutics companies are taking to developing vaccines for COVID-19 relies on what’s called an mRNA (messenger RNA, which essentially provides cells with protein production instructions) vaccine, a relatively novel method that hasn’t yet resulted in a vaccine approved for human use (though approved mRNA vaccines do exist for veterinary treatment). Making mRNA is a fairly specialized affair, and one biotech startup that focuses on its production has raised $17 million in special purpose funding to ramp up its manufacturing capacity.

Boston-based GreenLight Biosciences raided the additional funding from a combination of new and existing investors, including Flu Lab, Xeraya Capital, and Board Capital, and will use the new funds to both expand its mRNA production capacity in order to support the creation of “billions of doses” of potential COVID-19 vaccines for use in trials and eventual deployment, should any candidates prove effective.

Meanwhile, GreenLight is also developing several different versions of its own mRNA-based vaccine candidates to potentially prevent individuals from contracting SARS-CoV-2, the virus that leads to the COVID-19 infection. Some of the funding will also go towards its work in this area.

Various companies have spun up mRNA vaccine candidate development, and some have already entered into clinical trials, in response to the current global COVID-19 pandemic. These mRNA vaccines essentially work by providing a set of specific instructions to a person’s cells to produce proteins that are capable of blocking a virus, preventing it from getting a foothold in the body. It’s a different approach from traditional vaccine development, which involves using either deactivated, or small doses of activated actual virus to trigger an immune response in individuals.

mRNA vaccines have that advantage of being relatively safe because they contain no actual virus, with shorter pre-clinical development times as well, meaning the whole cycle from development to testing and deployment is shortened. That’s made them a popular area of focus and investment specifically to handle outbreaks and pandemics, but as mentioned, thus far none has been fully developed and approved for human treatemen.

This investment is a bet that mRNA vaccines not only prove effective in humans, but that they become a valuable and ongoing resource in curbing not only this pandemic, but other viral threats, including the existing standard influenza and others.

#biotech, #boston, #coronavirus, #covid-19, #drugs, #flu-lab, #health, #infection, #manufacturing, #recent-funding, #science, #startups, #tc, #vaccination, #vaccine, #vaccines, #virus

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NWU researchers develop a throat-worn wearable that could offer early warnings for COVID-19 patients

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 via at-home and in-clinic monitoring about its effectiveness. The hardware involve 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 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 frontline healthcare workers, offering them what will hopefully be an early warning sign of any oncoming illness, so that 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.

#ambient-intelligence, #biotech, #chicago, #coronavirus, #covid-19, #fever, #hardware, #illness, #infection, #kinsa, #northwestern-university, #startups, #tc

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LabCorp’s at-home COVID-19 test kit is the first to be authorized by the FDA

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.

#articles, #biotech, #coronavirus, #covid-19, #diabetes, #food-and-drug-administration, #health, #infection, #labcorp, #life-sciences, #science, #tc, #telemedicine, #united-states

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3D-printed glasses startup Fitz is making custom protective eyewear for healthcare workers

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.

#articles, #ceo, #clothing, #contact-lens, #coronavirus, #corrective-lenses, #covid-19, #equipment, #eyewear, #gadgets, #glasses, #hardware, #infection, #ipad, #louisiana, #new-york, #startups, #tc, #texas

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LA COVID-19 antibody study adds further support for a higher-than-suspected infection rate

A new study conducted by the University of Southern California along with the LA County Department of Public Health indicates the presence of antibodies for COVID-19 in between 2.8 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% 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% 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 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, as 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.

#california, #coronavirus, #covid-19, #health, #infection, #medicine, #official, #science, #stanford, #tc

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Curative received FDA emergency use authorization for its novel COVID-19 tests

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.”

#amplifiers, #biology, #biotechnology, #dcvc, #disease, #food-and-drug-administration, #fred-turner, #infection, #long-beach, #los-angeles, #physician, #rt, #spokesperson, #supply-chain, #tc, #ucla, #united-states

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University of Oxford coronavirus vaccine trial aims to have 500 people in testing by mid-May

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.

#biotech, #coronavirus, #covid-19, #health, #infection, #inovio, #medicine, #moderna, #oxford, #science, #tc, #united-states, #vaccine, #vaccines

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New MIT machine learning model shows relaxing quarantine rules will spike COVID-19 cases

MIT has developed a new model of the spread of COVID-19 infection, based on publicly available data, combined with established epidemiological equations about outbreaks, and neural network-based inference. The model, described in a new report, proves accurate when trained on data spanning late January to early March in terms of anticipating the actual spread leading up to April 1 in different regions around the world, and it indicates that any immediate or near-term relaxation or reversal of quarantine measures currently in place would lead to an “exponential explosion” in the number of infections.

Researchers at MIT sought to develop a model based just on COVID-19 data, whereas others have used SARS or MERS information to inform their charting of the outbreak’s progress. Combining available COVID-19 info with a neural network-based estimation of the number of infected individuals who are under effective quarantine, and therefore no longer a likely risk of infection to others, allows theirs to go beyond existing models in terms of accurately modelling and predicting the effect of social distancing and isolation measures – and the impact should those measures be curtailed or withdrawn.

MIT’s model shows that the current infection plateau for COVID-19 in the U.S. and Italy will both take place sometime in the next week or so, which matches existing predictions available. That sounds like promising news, and it is in terms of the number of infected patients, and the impact on the healthcare system, but it absolutely should not be interpreted as meaning that this is when it’s okay to start relaxing the measures in place.

In fact, the study concludes that by “relaxing quarantine measures too soon, we have predicted that the consequences would be far more catastrophic,” according to model developer and MIT mechanical engineering professor George Barbastathis, when compared to a similar second-wave resurgence that occurred in Singapore after it began relaxing its own measures too early.

#articles, #covid-19, #health, #infection, #italy, #medicine, #mit, #neural-network, #prevention, #relaxation, #science, #tc, #united-states

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Using AI, Yes Health cuts costs, improves adherence for weight loss and diabetes treatment

Using a combination of machine learning and computer vision, Yes Health claims it can cut costs and improve adherence for behavioral-based treatments targeting diabetes, obesity and other chronic conditions.

Those claims, and the company’s technology based approach has netted the company a new $6 million in funding led by Khosla Ventures .

The company’s technology automates patient’s reporting requirements by allowing them to take a picture of their meals rather than entering their daily food intake into a system. The company’s software recognizes meals from the images and converts that information into data that physicians and patients can use to monitor their progress.

If the ease of use for patients is one selling point, then the company’s automated messaging service is another. Using computer generated prompts instead of human consultations reduces the cost of the service and ultimately the price that folks have to pay.

 Founded by Alexander Petrov, a former PayPal executive who is, himself, pre-diabetic, Yes Health takes the therapies that have been pioneered by companies like Virta Health and Omada and makes them easier for patients to manage. 

“The biggest difference is that we have a level of personalization that then translates into engagement that is very unique,” says Petrov. “We are doing it through what we call an image-based in-the-moment approach… We capture analyze and share data not just through text but through images.”

The company, which launched six years ago, is working with Blue Shield of California and other healthcare partners. Yes Health has tens of thousands of paying members, according to Petrov, and the vision is to reach millions of people. 

Yes Health sells through both healthcare plans and direct to consumers — and the market the company hopes to address is huge. Roughly 34 million Americans had diabetes in 2018, according to data from the CDC and another 88 million are considered pre-diabetic. The cost of caring for these conditions in the US is an astonishing $327 billion each year. Healthcare costs for these patients can also reach more than 230% of the average American’s healthcare expenditures.

These issues take on new significance given the COVID-19 epidemic. Conditions like diabetes or obesity are linked to increasing chances of fatality from COVID-19 infection, according to reports.

“Americans are more conscious than ever about their health, and digital health has become one of the most important markets for innovation,” said Samir Kaul, founding partner and managing director of Khosla Ventures, in a statement. “Yes Health is proven to tackle difficult and costly chronic conditions through an AI-augmented and all-mobile solution, aligning it with our firm’s thesis in healthcare.”

 

#articles, #artificial-intelligence, #california, #diabetes, #executive, #health, #health-care, #healthcare, #infection, #khosla-ventures, #machine-learning, #medicine, #obesity, #omada, #paypal, #tc, #united-states

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Scanwell begins 1,000 person study for at-home antibody test for COVID-19

At-home antibody testing for COVID-19 is the subject of ample debate among the scientific and medical community, with some seeing it as a necessary step in the process of selectively re-opening parts of the economy through verification of individuals with immunity within the community, and others debating the accuracy and efficacy of currently available testing methods. Regardless of which side you’re on, it remains true that further testing is needed, and startup Scanwell has begun a sizeable study for its at-home antibody test, while it continues to work with the FDA on emergency use authorization for the diagnostic.

Scanwell is working with the state of North Carolina and Raleigh-based Wake Forest Baptist Health to distribute 1,000 of its at-home antibody test kits to a random sampling of citizens, funded in part by $100,000 from the state legislature. The sample population, chosen from the patient pool of Wake Forest Baptist Health’s system, and meant to be a statistically representative snapshot of the larger population, will get a finger-prick blood sample collection kit by mail, every month for a full year, in order to hopefully track the virus and immunity over time.

The Scanwell test can only be used for research purposes at this time, since it hasn’t yet received an emergency use authorization by the FDA. The FDA has so far specifically not authorized any at-home tests for COVID-19, including those supported by telemedicine, but it has recently updated its guidance to note that it “sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection,” and it says it is in the process of actively pursuing the development of tests that fit that profile in partnership with diagnostic companies.

LA-based Scanwell Health, which already provides at-home diagnostics for detecting UTIs, announced its work on securing FDA authorization for use of its at-home serological antibody test last month. The test kits can provide results in as little as 15 minutes once they’re received by diagnostic labs, but questions have been raised about the general accuracy of antibody testing overall regarding COVID-19, and there’s still some debate about the nature and duration of post-infection immunity for people who have contracted and recovered from the virus.

Better understanding immunity and who has recovered are key ingredients in any attempt to gradually relax isolation restrictions, so immunity testing is a core component that. It’s something that will be needed at scale, along with infection testing through existing molecular testing methods, and contact tracing, like the system being put in place through Apple and Google.

#apple, #coronavirus, #covid-19, #fda, #food-and-drug-administration, #google, #health, #infection, #medicine, #north-carolina, #raleigh, #science, #tc, #telemedicine

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Potential new treatment for COVID-19 uncovered by BenevolentAI enters trials

BenevolentAI, a startup which has raised $292 million to apply AI to create drugs faster, today says it has uncovered an already approved drug as a potential treatment for COVID-19, after it applied its AI platform and team to the problem. The revelation, which has now appeared in peer-reviewed scientific journals and has already entered clinical trials with a major pharmaceutical company, could offer a glimmer of hope to a world locked-down by the pandemic.

In February, BenevolentAI set up a specialist scientific team and launched an investigation using its drug discovery platform.

Baroness Joanna Shields, CEO of BenevolentAI, explained: “In response to the COVID-19 global health emergency, we turned our AI drug discovery and development platform toward understanding the body’s response to this novel infectious disease.”

Key to their approach was that “rather than focusing solely on drugs that could affect the virus directly, we explored ways to inhibit the cellular processes that the virus uses to infect human cells,” she said.

The idea was to identify approved drugs that could potentially stop the progression of COVID-19, inhibit the “cytokine storm” and reduce the inflammatory damage associated with this disease.

Diseases such as covid-19 and influenza can be fatal due to an overreaction of the body’s immune system called a cytokine storm.

Cytokines are small proteins released by many different cells in the body, including those of the immune system where they coordinate the body’s response against infection and trigger inflammation.

The body’s response to infection goes into overdrive when SARS-CoV-2 – the virus behind the COVID-19 pandemic – enters the lungs, triggering an immune response, and attracting immune cells to the region to attack the virus. This resulting in localized inflammation. Some people experience worse symptoms than others at this point. But in some people, excessive or uncontrolled levels of cytokines are released which then activate more immune cells, resulting in ‘hyperinflammation’ which can seriously harm or even kill the person.

BenevolentAI’s team fed everything they knew about COVID-19, and the drugs that could inhibit the cellular processes that the virus uses, into their platform.

In an interview with TechCrunch, Peter Richardson, BenevolentAI’s VP of Pharmacology, explained how the discovery came about.

“Using the BenevolentAI Knowledge Graph there were two processes. One was finding the connections, and the regulators,” he said.

“It’s incredibly, incredibly difficult to hold in your head what’s irrelevant, all the time, without having the Knowledge Graph to show you the basic points. It’s really good at showing the basic interactions that are so important in understanding a biological process. Cellular tracking is an amazingly complicated thing to process.”

But, he said, the BenevolentAI platform handled the information with aplomb: “This took an hour for the platform to process.”

The next process was for the human team to find possible drugs to inhibit regulators. These were then fed into the Knowledge Graph. Richardson said this “took roughly half an hour to process.”

The result was that they identified baricitinib as a potential drug with both anti-viral and anti-cytokine properties, with 90 minutes of computing time, inside three days of additional human work.

Benevolent’s research findings were published in The Lancet in early February and again twice in the Lancet Infectious Diseases journal. These proposed baricitinib as a potential treatment with both anti-viral and anti-inflammatory properties for COVID-19 patients admitted to hospital prior to the development of critical lung damage.

By March, investigator-led studies began recruiting and treating infected patients with baricitinib. Today, Eli Lilly and the US National Institute for Allergies and Infectious Diseases (NIAID) have announced that the drug will now begin it’s first large randomized trial in COVID-19 patients.

Baricitinib, sold as a prescription drug called Olumiant, is an already approved drug developed by Eli Lilly and Incyte for the treatment of rheumatoid arthritis.

The randomized trial announced by Eli Lilly with NIAID will investigate the efficacy and safety of baricitinib as a potential treatment for patients with serious COVID-19 infections.

The study will begin in the US in late April with planned expansion to additional sites in Europe and Asia, with the results being expected within the next two months. This new trial joins a Canadian government randomised trial already underway assessing baricitinib as a potential treatment.

Commenting, Shields said: “We are pleased that Eli Lilly is progressing baricitinib to clinical testing for COVID-19 patients. While we wait for a vaccine to be developed, there is an immediate need for medicines that can prevent life-threatening respiratory and other serious complications of COVID-19 infections.”

Daniel Skovronsky, M.D., Ph.D., Lilly’s chief scientific officer and president of Lilly Research Laboratories said: “Lilly is moving at top speed and using all available resources to help fight this pandemic. Developing potential therapeutic medicines for COVID-19 is part of our vital and humanitarian mission.”

Professor Justin Stebbing from Imperial College, London, who has been collaborating on this work between Eli Lilly and BenevolentAI, also commented, saying: “There are no specific therapeutic agents for any coronavirus infections – we rely on quarantine, isolation and public health policies to prevent disease spread, and on supportive care measures for those who become ill. What we lack is a specific agent to treat the infected and, optimally, decrease viral shedding and subsequent transmission. The results of such trials will be central to clinical care as the outbreak continues and we anticipate that this treatment will improve mortality and reduce the pressure on hospitals and ICU’s worldwide. This research is notable for its incredible speed from computer to bench and bedside within a few months.”

Commenting, Richardson added: “If you turned the BenevolentAI 250-person team and turned all of them into 65-year old ex-pharmacology teachers, it would have taken probably a year to come up with this treatment. Instead, it took my three colleagues working so two hours a day, and myself working full time, three days to come up with this. We’ve gone from computer to bedside, as it were, in two months.”

#artificial-intelligence, #asia, #benevolentai, #ceo, #coronavirus, #covid-19, #covid-19-updates, #disease, #drug-discovery, #eli-lilly, #europe, #infection, #influenza, #london, #medicine, #pharmaceutical, #rheumatoid-arthritis, #tc, #techcrunch, #united-states, #virus

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A new FDA-authorized COVID-19 test doesn’t need a lab and can produce results in just 5 minutes

There’s a new COVID-19 test from healthcare technology maker Abbott that looks to be the fastest yet in terms of producing results, and that can do so on the spot right at point-of-care, without requiring a round trip to a lab. This test for the novel coronavirus causing the current global pandemic has received emergency clearance for use by the U.S. Food and Drug Administration, and will begin production next week, with output of 50,000 per day possible starting next week.

The new Abbott ID NOW COVID-19 test uses the Abbott ID NOW diagnostics platform, which is essentially a lab-in-a-box that is roughly the size of a small kitchen appliance. It’s size, and the fact that it can produce either a positive result in just five minutes, or a negative one in under 15, mean that it could be a very useful means to extend coronavirus testing beyond its current availability to more places including clinics and doctor’s offices, and cut down on wait times both in terms of getting tested and receiving a diagnosis.

Unlike the rapid tests that have been used in other countries, and that received a new type of authorization under an FDA guideline that doesn’t confirm the accuracy fo the results, this rapid testing solution uses the molecular testing method, which works with saliva and mucus samples swabbed from a patient. This means that it works by identifying a portion of the virus’ DNA in a patient, which means it’s much better at detecting the actual presence of the virus during infection, whereas other tests that search the blood for antibodies that are used in point-of-care settings can only detect antibodies, which might be present in recovered patients who don’t actively have the virus.

The good news for availability of this test is that ID NOW, the hardware from Abbott that it runs on, already “holds the largest molecular point-of-care footprint in the U.S.,” and is “widely available” across doctor’s offices, urgent care clinics, emergency rooms and other medical facilities.

In total, Abbott now says that it believes it will produce 5 million tests in April, split between these new rapid tests and the lab tests that it received emergency use authorization for by the FDA on March 18.

Testing has been one of the early problems faced by the U.S. in terms of getting a handle on the coronavirus pandemic: The country has lagged behind other nations globally in terms of per capita tests conducted, which experts say has hampered its ability to properly track and trace the spread of the virus and its resulting respiratory disease. Patients have reported having to go to extreme lengths to receive a test, and endure long waits for results, even in cases where exposure was likely and their symptoms match the COVID-19 profile.

#abbott, #biotech, #coronavirus, #covid-19, #food-and-drug-administration, #health, #healthcare, #infection, #medicine, #science, #tc, #united-states, #veterinary-medicine, #viruses

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The FDA just okayed multiple 15-minute blood tests to screen for coronavirus, but there are caveats

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 that 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 organization’s 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 availability 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, one 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.

#china, #coronavirus, #covid-19, #fda, #health, #infection, #medicine, #science, #singapore, #taiwan, #tc, #united-states, #viruses

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