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.
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.
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 for front-line healthcare workers in need of the best protection they can get.
Fitz Protect is a version of Fitz’s eyewear 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.
Healthcare 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 front-line doctors and 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, to 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 eyewear. 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.
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.
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.”
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.”
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