Testing for COVID-19 has been somewhat of a roller coaster in the last few weeks. With each day, the FDA pushes forward in its efforts to expedite the review and rollout of sorely need COVID-19 diagnostic testing. It has enabled the Emergency Use Act, which relaxes standards during a time of crisis.
On March 30 the agency revealed that, since January, it has worked with more than 230 test developers – who have either already submitted requests for FDA emergency authorization of their product or are expected to submit. It also specifies that 22 have already been granted authorization.
One of the most notable of these new testing kits is Abbott’s ID Now COVID-19, The firm boasts of being able to produce 50,000 tests per day. The company announced that it plans on producing five million tests a month.
The Emergency Use Act requirement has been active since February, but in mid-March the FDA posted an update to the policy saying that it would begin permitting certain COVID-19 tests that haven't yet received an EUA, as long as they were actively working towards a clearance.
“The FDA’s regulations have not hindered or been a roadblock to the rollout of tests during this pandemic,” FDA Commissioner Dr. Stephen Hahn, wrote in the memo. “Every action the FDA has taken during this public health emergency to address the COVID-19 pandemic has balanced the urgent need to make diagnostic tests available with providing a level of oversight that ensures accurate tests are being deployed.”
However, the EUA has caused some confusion in the past. In mid-March a slew of diagnostic-testing startups announced new services that would deliver at-home COVID-19 testing kits to consumers.
Shortly after the take-home-testing companies announced their plans, the FDA released an alert to consumers warning of "unauthorized fraudulent COVID-19 test kits," which specifically noted that "the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19." Since then a majority of the tests were rescinded.
But within the last week we are continuing to see more companies from the digital health space jump into the testing space.
Ready Responders is rolling out a new home-based COVID-19-testing service administered by a healthcare professional that uses telehealth support. The service will start in Southeastern Louisiana, Reno and Las Vegas, in Nevada, and is planned to be moving into new markets by the end of the week.
“When a patient is interested in receiving care form Ready Responders, they reach out via our mobile app or phone,” Dr. Olan Soremekun, chief medical officer for Ready Responders, wrote in an email to MobiHealthNews. “From there, we’ll leverage our telehealth capabilities to screen the patient for symptoms and dispatch the appropriate medical professional to the patient’s home. Upon arrival, the Responder, following the proper protocols, will assess the patient and administer an FDA-approved COVID-19 tests, when necessary.”
Last week the company announced a $48 million Series B round led by Deerfield Management Ventures.
While the test is done in the home, Sormekun said that this is different from the home-tests that the FDA warned against.
“The FDA warned against leveraging non-authorized, at-home test kits that were produced by companies for consumers to administer the tests themselves,” said Soremekun. “Ready Responders, however, only uses FDA-authorized COVID-19 test kits, which are proven to be both safe and accurate. In addition, our team is made up of highly trained professionals, including nurses, paramedics and EMTs, who administer the tests, not consumers, while following the proper procedures and ensuring accurate results.”
Meanwhile, San Diego-startup Cue Health scored $13 million from the department of Health and Human Services Biomedical Advanced Research and Development authority in order to fund its portable COVID-19 diagnostic test.
The test will eventually be connected to a web-based platform that can give patients information about their test results, as well as other features, including telemedicine consultations.
The plan is for the new funds to go to “accelerate the development, validation and FDA-clearance” of such a system.
“We have worked with the BARDA team for the past two years developing and testing a 20-minute, molecular influenza test designed for home and point-of-care use,” Ayub Khattak, CEO of Cue Health, said in a statement. “Our connected platform could serve as a critical tool in identifying the SARS-CoV-2 virus. Rather than waiting days for results or sending samples off to a lab, having test results in 25 minutes could drastically improve our ability to contain the spread of the virus for this and future pandemics.”
WHY IT MATTERS
During this pandemic the US has had a shortage of tests that were ready. According to a report by Oxford University's Our World in Data, the per capita number of tests in the U.S. is 40 times lower than South Korea's.
During MassChallenge’s innovation summit last week Margaret Bourdeaux, research director at Harvard Medical School, explained that testing, along with tracing contamination, isolating those in contact and quarantining those infected with COVID-19, was key to containing the disease.
"We can do all those things, those things have been done [before] in the United States ... It does require innovation," she said. "Until that framework has come together, we do have to lean in on physical distancing, because that is the only thing we can do to break transmission. Once we start rolling out testing, contract tracing, safe and supportive isolation, and quarantine, we can start to relax those measures, and right now it's up to us. My only concern is not aligning policy and executing on the plan, then I'm worried."
THE LARGER TREND
Innovation around testing efforts aren’t unique to the United States. Worldwide we are seeing companies and governments rushing to bring new tools to market. Just yesterday morning Singapore- medtech company Biolidics announced that it inked a manufacturer agreement with a diagnostic-kit manufacturer to customize and manufacture its rapid test kits for COVID-19. The first batch of test kits is expected to be available in April 2020.
Meanwhile in the UK, digital hospital Medbelle announced it will sell COVID-19 test kits to private patients at cost in an attempt to aid the NHS in its efforts to better understand the virus and to expand testing capabilities in the UK.