The surge of interest in testing for the COVID-19 pathogen has led to some innovative tests and test strategies, including at-home tests. However, the FDA has indicated that it is wary of both at-home testing and specimen collection in other than supervised settings, a policy that is meeting with criticism from some quarters, but not all.
Everlywell Inc., of Austin, Texas, had announced March 18 that it had a test kit available for shipment that would have permitted at-home collection of samples that could have been analyzed via telehealth. The company indicated it had 30,000 such kits available, but the company had to withdraw the direct-to-consumer offer. The kits are available to health care professionals.
Among the companies that have shelved plans to distribute kits to consumers is Nurx Inc., of San Francisco, which had partnered with Molecular Testing Labs of Vancouver, Washington, to develop the tests. Other firms have flirted with the at-home market for these tests, including Carbon Health, also of San Francisco, which likewise stood down a similar plan.
The FDA discussed briefly its position on at-home testing in a FAQ for coronavirus diagnostics, stating that its policy for COVID-19 testing excluded at-home testing and self-collection samples. The agency encouraged developers to discuss their validation efforts for such tests “early in their development process.”
Danielle Bradnan, an associate with Lux Research Inc., of New York, described the FDA’s position as "baffling.” Bradnan said that while the FDA “is trying to achieve a delicate balance, trying to facilitate as many tests as possible while ensuring safety and accuracy, it is unclear why it is doing this.”
Test samples must be shipped to an independent, CLIA-certified lab for many test collection sites, Bradnan said, adding that the process in question “is identical to the process of at-home testing companies.
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