FDA approves first SARS-CoV-2 diagnostic test using premarket review process

March 18, 2021

The U.S. Food and Drug Administration (FDA) granted marketing authorization for the BioFire Respiratory Panel 2.1 (RP2.1), a diagnostic test for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs, according to a news release from the agency.

The diagnostic test, which had an emergency use authorization (EUA), was granted marketing authorization using the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.

Because the test was granted De Novo authorization, it will be the first SARS-CoV-2 diagnostic test that the FDA will permit to be marketed beyond the public health emergency.

The FDA said the grant of the De Novo request for this test is based on additional data showing validation beyond what is needed for emergency use authorization. The agency reviewed data from a clinical study of more than 500 test samples and a variety of analytical studies, which demonstrated a reasonable assurance that the BioFire RP2.1 was safe and effective at identification and differentiation of various respiratory viral and bacterial pathogens. 

With granting of the De Novo for the BioFire RP2.1, the FDA said it also has revoked the EUA for this device, which was initially authorized for emergency use in May 2020. This EUA revocation and De Novo authorization do not impact the availability other tests under EUA.

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