FDA allows marketing of first SARS-CoV-2 diagnostic test using the traditional pre-market review process

The U.S. Food and Drug Administration today 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 (NPSs) obtained from individuals. word. suspected of COVID-19 and other airway infections. The diagnostic test, with an emergency authorization capability (EUA), granted marketing authorization using the De Novo pre-marketing assessment route, a regulatory pathway for devices of a new type with low to moderate risks. The granting of this De Novo request is an important step in the FDA’s response to the COVID-19 pandemic because it is the first SARS-CoV-2 diagnostic test that can be allowed to go beyond the public health emergency. market.

“Today’s actions are an excellent demonstration of the FDA’s work to protect public health in emergencies and beyond,” said FDA Acting Commissioner Janet Woodcock, Managing Director. made available under EUA; and we continue to work with diagnostic manufacturers to take the next step in ensuring that products are reviewed by the FDA for safety and efficacy and authorized under our traditional marketing authorities. Although this is the first marketing authorization for a diagnostic test with a traditional pre-market review process, we do not expect this to be the last and look forward to working with medical device developers to move their products through our traditional review routes. ”

The grant of the De Novo request for this test is based on additional data showing the validation that goes beyond what is required for authorization for emergency use. The FDA reviewed data from a clinical study of more than 500 test samples and a variety of analytical studies, which showed a reasonable assurance that the BioFire RP2.1 is safe and effective in identifying and identifying various respiratory viral and bacterial pathogens. distinguish.

With the award of the De Novo for the BioFire RP2.1 today, the FDA also withdrew the EUA for this device, which was initially approved for emergency use in May 2020. This EUA revocation and De Novo authorization do not affect the availability of other tests. under EUA.

“Safety, efficiency and innovation remain important priorities for CDRH. Today’s action underscores the FDA’s ongoing commitment to expand access to testing, while providing important guarantees through our EUA authority and traditional review channels, ‘said Jeff Shuren, MD, JD, Director of the FDA’s Device Center and radiological health.

The BioFire RP2.1 is for use only in persons suspected of having respiratory tract infections, including COVID-19. This diagnostic test is for the detection and identification of specific viral and bacterial nucleic acids of individuals that show signs and / or symptoms of respiratory infection, and helps with the diagnosis of respiratory infection if used in conjunction with other clinical and epidemiological information. Test results should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Positive results of this test do not exclude contamination with other organisms. The drug (s) detected by the BioFire RP2.1 may not be the definitive cause of disease. Negative BioFire RP2.1 results in a respiratory disease resulting from infection with pathogens not detected by this test, or lower respiratory tract infection that may not be detected by an NPS sample. Additional laboratory tests (eg, bacterial and viral culture, immunofluorescence, and radiography) may be required when evaluating a patient with possible respiratory infection.

Together with this De Novo authorization, the FDA draws up criteria called special controls that define the requirements for labeling and performance testing. If complied with, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type. This action also creates a new classification of regulations, which means that subsequent devices of the same type with the same intended use can pass through the FDA’s 510 (k) path, allowing devices to gain approval by showing significant equivalence with a predicate device. .

The FDA has granted the marketing authorization to BioFire Diagnostics LLC.

The FDA, an agency within the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of food supply, cosmetics, nutritional supplements, products that emit electronic radiation and for the regulation of tobacco products in our country.

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