Regulatory Focus™ > News Articles > 2020 > 3 > FDA: Flexible COVID-19 Testing Policy Doesn’t Apply to At-Home Tests

FDA: Flexible COVID-19 Testing Policy Doesn’t Apply to At-Home Tests

Posted 24 March 2020 | By Michael Mezher 

FDA: Flexible COVID-19 Testing Policy Doesn’t Apply to At-Home Tests

After warning consumers against “unauthorized fraudulent” at-home test kits for detecting coronavirus disease (COVID-19) last Friday, the US Food and Drug Administration (FDA) has clarified that such tests would not qualify for its policy aimed at speeding the availability of laboratory-based tests.
Testing for COVID-19 in the US was initially hampered by a faulty early version of a test developed by the Centers for Disease Control and Prevention and the limited availability of test kits distributed to states.
On 29 February, FDA eased restrictions on testing for COVID-19 by allowing certain laboratories certified to perform high-complexity testing to conduct tests for 15 days prior to submitting an emergency use authorization (EUA) request. FDA has since granted 15 EUAs to test developers and says that more than 65 laboratories have developed and validated their own tests under the policy.
According to the COVID Tracking Project, the US had conducted fewer than 10,000 tests as of 12 March, though that number climbed to more than 300,000 as of Tuesday.
While the availability of tests has increased significantly in the last two weeks, some companies, including Everlywell, Nurx and Carbon Health had previously announced plans to sell at-home test kits directly to consumers. Following FDA’s advisory, all three companies have said they will halt sales to consumers until FDA authorizes home-based testing or the self-collection of samples.
Another company, Scanwell Health, has said it plans to market a serological test for the virus but is pursuing an EUA before it plans to market the test.
In FDA’s advisory, the agency said it had not authorized any test kits for at-home use and warned that “fraudulent health claims, tests and products can pose serious health risks.” On Monday, FDA Commissioner Stephen Hahn reiterated that FDA “is not aware of any validated test available to purchase for home testing.”
In an update posted Monday to the agency’s Frequently Asked Questions for SARS-CoV-2, the virus that causes COVID-19, FDA explains that at-home tests or tests involving self-collected samples do not qualify for the agency’s policy for speeding the availability of laboratory and commercially developed tests.
FDA says it “sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection” and is working with developers who plan to introduce such products.
While FDA says that nasopharyngeal specimens are “the preferred choice for swab-based SARS-CoV-2 testing,” the agency also offers three alternatives that may be more comfortable for patients when nasopharyngeal testing is not available, including oropharyngeal, mid-turbinate or anterior nares specimens. The latter two of those options would also qualify for “onsite self-collection” in symptomatic patients.
FDA says it encourages companies looking to develop at-home tests or tests involving the self-collection of samples to discuss their validation plans with the agency early on.


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