- For immediate release:
Today, the US Food and Drug Administration has 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 (NPS) obtained from individuals suspected COVID-19 and other respiratory tract infections. The diagnostic test, which had an Emergency Use Authorization (USA), received marketing authorization using the De Novo pre-marketing review route, a regulatory route for low to moderate risk devices of a new type. The granting of this De Novo order marks an important step in the FDA’s response to the pandemic COVID-19 because it is the first SARS-CoV-2 diagnostic test that will be allowed to be marketed in addition to the public health emergency.
“Today’s action is a great demonstration of the FDA’s work to protect public health in emergency response situations and beyond,” said FDA Acting Commissioner Janet Woodcock, MD “We guarantee that tests will be made available quickly under the USA; and we continue to work with diagnostic manufacturers to take the next step to ensure that products are evaluated by the FDA for safety and efficacy and authorized for marketing by our traditional pre-marketing authorities. While this is the first marketing authorization for a diagnostic test using a traditional pre-marketing review process, we do not expect it to be the last and look forward to working with medical product developers to move their products through our traditional review paths. . “
The granting of the De Novo order for this test is based on additional data showing validation beyond what is necessary 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 reasonable assurance that BioFire RP2.1 was safe and effective in identifying and differentiating various respiratory and viral bacterial pathogens. .
With the De Novo grant for BioFire RP2.1 today, the FDA also revoked the USA for this device, which was initially authorized for emergency use in May 2020. This revocation of the USA and De Novo authorization does not affect the availability of other tests under USA.
“Safety, effectiveness and innovation remain important priorities for the CDRH. Today’s action underscores the FDA’s continued commitment to expanding access to tests, while providing important protections through our U.S. authority and traditional review paths, ”said Jeff Shuren, MD, JD, director of the FDA Radiological Health and Devices Center.
BioFire RP2.1 is for use only in individuals with suspected respiratory tract infections, including COVID-19. This diagnostic test is for the detection and identification of viral and bacterial nucleic acids specific to individuals who exhibit signs and / or symptoms of respiratory infection and helps in the diagnosis of respiratory infection if used in conjunction with other clinical and epidemiological information. The test results should not be used as the sole basis for diagnosis, treatment or other patient management decisions. The positive results of this test do not exclude co-infection with other organisms. The agents detected by BioFire RP2.1 may not be the definitive cause of the disease. The negative results of BioFire RP2.1 in the setting of a respiratory illness may be due to infection with pathogens that are not detected by this test or infection of the lower respiratory tract that may not be detected by an NPS sample. Additional laboratory tests (for example, bacterial and viral culture, immunofluorescence and radiography) may be necessary when evaluating a patient with a possible respiratory tract infection.
Along with this De Novo authorization, the FDA is establishing criteria called special controls that define requirements related to labeling and performance testing. When met, special controls, in combination with general controls, provide reasonable assurance of safety and effectiveness for such tests. This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use can pass through the FDA’s 510 (k) path, whereby the devices can obtain clearance demonstrating substantial equivalence to a predicate device. .
The FDA has granted marketing authorization to BioFire Diagnostics LLC.
The FDA, an agency of the United States 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 security of the supply of food, cosmetics, dietary supplements, products that emit electronic radiation and for the regulation of tobacco products in our country.
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