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The Los Angeles-based diagnostics startup developed a coronavirus test that takes just 15 minutes to complete at home, and it’s aiming to roll it out to the masses in the US, according to TechCrunch. Once the tests are made available, eligible users can receive it via next-day delivery and will be guided through the test and their results by telehealth partner Lemonaid’s clinicians.
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The test is awaiting FDA approval — and we think the US’ clearance process could delay other tests from becoming available in the US, which is already lagging behind other nations in testing. While the test is currently in process of securing approval via the FDA’s accelerated emergency certification program, it isn’t expected to hit the US market for another six to eight weeks.
Any delays that restrict coronavirus tests from getting into the hands of the US public could be catastrophic, since infected individuals without symptoms are believed to be driving the spread of the coronavirus. And with the US already trailing a litany of nations in coronavirus testing, deploying tests to the US public as quickly as possible will be vital in containing the spread of the coronavirus.
We’ve seen the US government ease restrictions on digital health tools amid the pandemic — and we wouldn’t be surprised to see the FDA become more lax with its own clearance process. Medicare recently announced the immediate, nationwide expansion of telemedicine coverage in a move designed to help vulnerable seniors remain home and limit their potential exposure to the novel coronavirus.
And government organizations including the CDC are encouraging patients to seek medical treatment and advice virtually to mitigate further spread of the virus. With at least 13,000 people across the US testing positive for the novel coronavirus as of the evening of March 19th, we think the FDA’s hand may be forced to follow the lead of the US government and ease its own restrictions on the review of at-home diagnostic tests to speed up the process of getting these tests into the hands of the US public.
And the FDA should strongly consider doing so, since the rising number of coronavirus infections — and deaths in the US — can be stymied by diagnosing coronavirus patients and isolating individuals who test positive. For example, the World Health Organization’s assistant director general Bruce Aylward recently credited rapid testing of suspect cases, the immediate isolation of suspected or confirmed cases, and quarantines of 2 weeks for close contacts with stopping the spread of the coronavirus in China.
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