The FDA has granted Salt Lake City-based BioFire Diagnostics marketing authorization for its BioFire Respiratory Panel 2.1 diagnostic test. The grant of this De Novo request marks an important step in the FDA’s response to the covid-19 pandemic because it is the first SARS-CoV-2 diagnostic test that will be permitted to be marketed beyond the public health emergency.
“Today’s action is a great demonstration of the FDA’s work to protect the public health in emergency response situations and beyond,” says FDA Acting Commissioner Janet Woodcock, MD. “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. While this is the first marketing authorization for a diagnostic test using a traditional premarket review process, we do not expect this to be the last and look forward to working with developers of medical products to move their products through our traditional review pathways.”
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 FDA 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.
The BioFire Respiratory Panel 2.1 is a multi-analyte molecular test that simultaneously detects 22 different viruses and bacteria associated with respiratory tract infections, including SARS-CoV-2, from a single nasopharyngeal swab. It was first granted an EUA in May 2020.
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