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FDA Issues Emergency Authorization to Two More COVID-19 Diagnostic Tests

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The US Food and Drug Administration has issued an additional two COVID-19 diagnostic Emergency Use Authorizations (EUA), bringing the total to four so far in the outbreak. The authorizations will help to increase national testing capacity in the US, a crucial factor in the rapid identification and containment of cases.

Roche Molecular System’s cobas SARS-CoV-2 test
was authorized on March 12, 2020, becoming the third COVID-19 diagnostic test, and first commercially distributed test, granted an EUA. The EUA was issued within 24 hours of the FDA receiving the application, and since the test was pre-positioned, laboratories were able to immediately begin running tests upon authorization.

Following this, the fourth COVID-19 diagnostic EUA was
issued to Thermo Fisher on March 13, 2020, for its TaqPath COVID-19 Combo Kit. The test can be used immediately to detect nucleic acid from SARS-CoV-2 (the virus that causes COVID-19) and can provide results within four hours of a sample being received by a lab.

FDA Commissioner Stephen M. Hahn commented on the developments in a
recent press release: “This action today shows our agency’s dedication to working around the clock to review and authorize diagnostics during this public health emergency. We have been engaging with test developers and encouraging them to come to the FDA and work with us. Since the beginning of this outbreak, more than 80 test developers have sought our assistance with development and validation of tests they plan to bring through the Emergency Use Authorization process. Additionally, more than 30 laboratories have notified us they are testing or intend to begin testing soon under our new policy for laboratory-developed tests for this emergency. The number of products in the pipeline reflects the significant role diagnostics play in this outbreak and the large number of organizations we are working with to bring tests to market.”

What is an EUA?

EUA enables unapproved medical products or unapproved uses of medical products to be used in an emergency when there are no adequate, approved, and available alternatives. The Secretary of the US Department of Health and Human Services determined on February 4, 2020, that COVID-19 was a public health emergency, and subsequently declared the circumstances justified the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19. On February 29, 2020, the FDA issued guidance enabling laboratories to use COVID-19 diagnostic tests they develop faster.