While a number of companies who currently offer at-home medical and health diagnostics had rushed to produce kits that would allow for self sample collection by people who passed a screening and believed they might have contracted the new coronavirus, the U.S. Food and Drug Administration (FDA) has updated its Emergency Use Authorization guidelines to private labs that specifically bar the use of at-home sample collection. This means startups, including Everlywell, Carbon Health and Nurx, will have to immediately discontinue their testing programs in light of the clarified rules.
The FDA issued the updated guidance on March 21, and though some of the companies had already begun to ship their sample collection kits to people, and even begun to receive samples back to their diagnostic laboratory partners, even any samples in-hand will not be tested, and will instead be destroyed in order to compel with the FDA's request. Carbon Health is continuing testing at its physical clinics, and notified TechCrunch of this update on Sunday evening, and an individual who ordered the Carbon Health test and sent back their sample provided the following email explaining the decision and what happens next:
We have been working hard to provide our patients every opportunity for COVID-19 testing and treatment, including exploring different avenues for testing.
This evening, we were notified by our lab partner, Curative Inc, that the 3/21/2020 FDA update for COVID-19 testing clarified that at-home sample collection is not covered under the EUA (U.S. Food and Drug Administration’s Emergency Use Authorization). Carbon Health is discontinuing distribution of the at-home sample collection kits effective immediately.
Based on this update by the FDA, we sincerely regret to inform you that you will not get a test result. If you have already shipped your kit back, the specimen will be destroyed by Curative, Inc using standard biohazard disposal. If you have not received your kit yet, please discard it upon receipt.
Please schedule an in-clinic visit at a Carbon Health clinic near you, if possible, to be tested using our traditional specimen collection by a clinician. The turn-around time for results is about 3-5 days from time of specimen collection.
Our goal was to facilitate at home specimen collection in order to keep patients safely in their homes while also providing another avenue for patients to be tested. This is a very dynamic time and we are working tirelessly to work with new partners to expand COVID-19 testing for our communities, as soon as possible. We are truly sorry for the frustration and inconvenience this has caused.
All three of the companies we spoke to that were working to distribute these tests had partnered with labs that were approved under the FDA emergency guidelines to perform COVID-19 diagnostics, and it was the understanding of all parties that at-home self collection via swab kits was included in the authorization. All three also said they were offering their tests at-cost, and seeking ways to defray even that cost to consumers through potential healthcare agency partnerships. Each also offered telehealth consultations for both the sample-gathering process, as well as for delivery of the results.
The FDA's goal with its emergency use authorization is to enable testing without sticking to its usual qualification process, but it must always balance accuracy and safety. It did grant emergency use approval to Cepheid's rapid point-of-care test last Friday, as well, which should expand availability of tests on-site in locations like hospitals and emergency medical care clinics, but this updated rule means that at-home tests will not, in the near-term, be a path towards expanding testing coverage in the U.S.
Another startup, Scanwell, has developed an in-home test that includes the diagnostics, using a serological test that looks for the presence of antibodies in a person's blood. This is still pending FDA approval, and the company is seeking that under the emergency use authorization, with an anticipated approval process time of around six to eight weeks.