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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.... 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.
