The FDA has issued the first authorization for an at-home COVID-19 test kit created by a diagnostics company called Pixel LabCorp. LabCorp said it’s planning on giving first access to health care workers and first responders.
Here’s LabCorp’s at-home #COVID19 test, which just got emergency approval from the FDA.
It’s called the “Pixel.”$LHhttps://t.co/dHPUMCqG5M pic.twitter.com/QUpTCQ0Osu
— Carl Quintanilla (@carlquintanilla) April 21, 2020
People taking this test would swirl a cotton swab just inside their nostril. When clinicians take samples for a COVID-19 test, they stick a swab very deep into a patient’s nose, to where the back of their nose meets the top of their throat. Self-administered nose swabs are just as accurate as those more invasive swabbing methods, according to an analysis done by UnitedHealth Group and the Gates Foundation. The FDA started allowing those types of swabs at the end of March, although the agency said they still had to be done under the supervision of a clinician.
According to the Verge, several biotech startups have created and tried to market at-home tests over the past month, claiming that they’re able to produce them under rules that allow certified labs to design and distribute their own tests. Ever the stick-in-the-mud, even in the middle of an unprecedented health crisis where urgency probably tops crossing every ‘t’ and dotting every ‘i’, the FDA has said that any test kit that allows people to collect their own samples at home needed additional authorization. Bravo, FDA. It’s exactly this type of bureaucratic caution that helped hamstring America’s ability to roll out testing. And here the White House is again, just allowing it to happen.
The LabCorp test, produced by its consumer-focused testing brand, Pixel, is the first to win that authorization, a major prize for the company. The laboratory portion of its test had already been approved for use, but it still relied on samples collected by health care workers.
Amazingly, when attacked about why these tests weren’t rolled out sooner, the FDA can simply point to the fact that the test was authorized under its “emergency use” rule which allows the expeditious roll out of products that didn’t go through the traditional testing screen.
Due to supply constraints, the test will be available only to health care workers, at least until supplies ramp up.
