Everlywell gains first FDA authorization for a standalone, at-home, COVID-19 test sample collection kit
Everlywell was one of the first startups to announce that it was working on a self-administered, at-home COVID-19 diagnostic kit, but it initially sought out to ship kits before regulators made clear that this was not in line with its guidelines. Everlywell then became intent on working with the FDA to secure a proper Emergency Use Authorization for its kits before sending any to consumers, and that approach has paid off with the U.S. drug regulator issuing an EUA for Everlywell’s tech today.
Everlywell‘s COVID-19 Test Home Collection Kit is the first standalone sample collection kit to be granted a proper EUA by the FDA. Other kits have been in use through physician-prescribed and directed collection, and others still have been authorized specifically for use with one test (where provider of both kit and test are the same). This approval is unique because Everlywell is offering its sample kit independent of any specific testing lab, and can work with a variety of labs to potentially provide a broader testing footprint.
The test kits are then sent to one of two labs currently authorized under separate EUAs for COVID-19 testing, and the administration notes that this could expand to other test providers …read more
Source: Tech Crunch