Everlywell gains first FDA authorization for a standalone, at-home, COVID-19 test sample collection kit

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 in future should they file for an EUA and provide the requisite data that goes along with the verification required for that emergency approval. The FDA cites Everlywell’s work in collecting and presenting data from studies including those supported by the Bill and Melinda Gates Foundation to show that samples collected at home using its nasal swab collection method remain stable during shipping.

That data is also now available to others looking to provide similar test kit offerings, the FDA notes, which should reduce the burden of proof on anyone looking to gain authorization for a competing product. That could potentially open up testing even further, reducing a bottleneck that many public health professionals see as one of the key drivers of a successful recovery.

“The authorization of a COVID-19 at-home collection kit that can be used with multiple tests at multiple labs not only provides increased patient access to tests, but also protects others from potential exposure,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health in a statement provided to TechCrunch. “Today’s action is also another great example of public-private partnerships in which data from a privately funded study was used by industry to support an EUA request, saving precious time as we continue our fight against this pandemic.”