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FDA Issues Three EUAs for At-Home Collection COVID-19 Tests

FDA maze of regulations
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May indicate that the FDA is moving to encourage more at-home collection options and increase testing availability in the home environment

The US Food and Drug Administration (FDA) announced Oct. 20, 2020, a reissue of two emergency use authorizations (EUAs) and a new EUA for COVID-19 tests. The three EUAs allow for at-home specimen collection for SARS-CoV-2 testing.

Wren Laboratories’ COVID-19 PCR Test is one of the three tests included in the Oct. 20 EUA announcements. Wren had initially been granted an EUA for its COVID-19 diagnostic test in August but had the EUA reissued to allow the use of saliva-based specimens and to permit at-home specimen collection.

The FDA also reissued another EUA for P23 Labs. P23’s TaqPath SARS-CoV-2 Assay received initial FDA authorization in the form of an EUA in late May, but the EUA was reissued to include saliva specimens that may be collected at home and without the supervision of a healthcare professional.

In addition to these two reissued EUAs, the FDA granted an initial EUA for Binx Health’s At-Home Nasal Swab COVID-19 Sample Collection Kit. This at-home collection kit is designed to be ordered based on an online questionnaire, and the sample can be collected at home.

While new EUAs have become commonplace this far into the public health emergency, the recent approval of three EUAs that are all focused on at-home specimen collection may indicate that the FDA is moving to encourage more at-home collection options and increase testing availability in the home environment.

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COVID-19 TESTING DATA