The U.S. Food and Drug Administration or FDA granted the first marketing authorization for a SARS-CoV-2 (COVID-19) diagnostic test using the De Novo review pathway, the traditional premarket review process. The test will now be permitted to be marketed beyond the public health emergency.
BioFire Diagnostics LLC’s BioFire Respiratory Panel 2.1 (RP2.1) diagnostic test was granted the marketing authorization for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of COVID-19 and other respiratory tract infections.
BioFire Diagnostics is U.S. subsidiary of French diagnostic solutions firm bioMérieux that is specialized in molecular syndromic infectious disease testing.
The diagnostic test, which had an Emergency Use Authorization (EUA) since May 2020, was granted marketing authorization using the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.
The FDA has also now revoked the EUA for BioFire RP2.1. This approval does not impact the availability other tests under EUA.
“We ensured there were tests made available quickly under EUA; and we continue to work with diagnostic manufacturers to take the next step of ensuring products are FDA reviewed for safety and effectiveness and authorized for marketing under our traditional premarket authorities ,” said FDA Acting Commissioner Janet Woodcock, M.D.
The marketing authorization was granted for this test based on additional data showing validation beyond what is needed for a EUA.
The FDA reviewed data from a multicenter prospective 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.
The BioFire RP2.1 SARS-CoV-2 assay demonstrated positive percent agreement (PPA) of 98.4 percent and negative percent agreement (NPA) of 98.9 percent.
The BioFire RP2.1 detects 22 respiratory pathogens, including SARS-CoV-2, to help clinicians quickly rule in and rule out common causes of respiratory illness in about 45 minutes. It runs on the fully automated BioFire Filmarray 2.0 and BioFire Torch Systems with only 2 minutes of sample preparation time.
The test aids in the diagnosis of respiratory infection if used along with other clinical and epidemiological information. The results of the test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Additional laboratory testing such as bacterial and viral culture, immunofluorescence and radiography, may be necessary when evaluating a patient with possible respiratory tract infection.
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