The U.S. Food and Drug Administration (FDA) has granted “emergency use authorization” to self-samples from people who are screened and believe they may be infected with a new coronavirus, while many companies currently offering home medical and health diagnostics have given them “emergency use authorization,” according to techCrunch, amedia outlet. The guidelines are updated to a private laboratory that specifically prohibits the use of sample collection at home. This means that start-ups, including Everlywell, Carbon Health and Nurx, will have to stop their detection procedures immediately under clear rules.
The FDA issued updated guidelines on March 21, although some companies have begun shipping their sample collection kits to people, and even began sending samples back to their diagnostic laboratory partners, requiring that even any samples on hand not be tested and destroyed to comply with FDA requirements. Carbon Health is continuing to test at its physical clinic and notified TechCrunch of this update sunday night, and provided the following email to individuals who ordered the Carbon Health test kit and sent back their samples, explaining the decision and what will happen next:
We are always working to provide patients with every opportunity to perform COVID-19 testing and treatment, including exploring different testing pathways.
This evening, our laboratory partner, Curative Inc. informed us that the FDA’s update to FDA COVID-19 on March 21, 2020 clarified that EUA (the U.S. Food and Drug Administration’s Emergency Use Authorization) does not cover home-collected samples. Carbon Health is discontinuing the distribution of the Home Sample Collection Kit, which is effective immediately.
Based on this FDA update, we sincerely and regret to inform you that you will not be able to obtain the test results. If you have already sent the kit back, Curative,Inc will destroy the specimen using standard biohazard disposal methods. If you have not received your kit, discard it at the time of receipt.
If possible, arrange a clinic visit at your nearby Carbon Health clinic for testing by clinicians using our traditional specimens. From the time of sample collection, the turnaround time of the results is approximately 3-5 days.
Our goal is to facilitate specimen collection at home so that patients can stay at home safely, while also providing another way for patients to be tested. This is a very dynamic time and we are working tirelessly with new partners to expand COVID-19 testing for our community as quickly as possible. We apologize for the frustration and inconvenience.
All three companies with whom TechCrunch spoke to are working to distribute these test kits have conducted COVID-19 testing in collaboration with laboratories approved under FDA Emergency Guidelines, as understood by all parties involved, that self-collection kits can be self-collected at home through cotton swabs. All three companies also said they would provide testing at cost and would look for ways to pay consumers through potential health care partnerships. Each agency also provides telemedicine consulting for the sample collection process and the delivery of results.
The FDA’s emergency use authorization goal is to test without following its usual certification process, but must always strike a balance between accuracy and safety. It did approve emergency approval for Cepheid’s rapid-use care teston on Friday, which should expand the availability of on-site testing at locations such as hospitals and emergency medical clinics, but the updated rules mean that home testing will not be a way to expand U.S. testing coverage in the short term.
Scanwell, another start-up, used serological tests to develop a home test kit, including a diagnosis, that detects the presence of antibodies in a person’s blood. That’s still waiting for FDA approval, and the company is seeking approval under an emergency use authorization, which is expected to take about six to eight weeks.