The US Food and Drug Administration (FDA) has granted marketing authorisation to BioFire Diagnostics’ SARS-CoV-2 test.
The BioFire Respiratory Panel 2.1 (RP2.1) diagnostic test secured a marketing permit for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from people suspected of Covid-19 and other infections related to the respiratory tract.
FDA granted the permit under the De Novo premarket review pathway, a regulatory pathway to review new type of low- to moderate-risk devices.
The new test is claimed to be the first SARS-CoV-2 diagnostic test that will be permitted to be marketed beyond the public health emergency.
FDA acting commissioner Janet Woodcock said: “Today’s action is a great demonstration of the FDA’s work to protect the public health in emergency response situations and beyond.
“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 authorised for marketing under our traditional premarket authorities.”
The De Novo request for this test was granted based on additional data that showed validation beyond what is needed for Emergency Use Authorization (EUA).
The FDA also reviewed data from a clinical study of more than 500 test samples and various analytical studies.
As the new test has been authorised through a traditional premarket review pathway, the FDA has revoked the EUA for this device that was initially authorised in May.
However, the FDA stated that the EUA revocation and De Novo authorisation ‘do not impact the availability of other tests under EUA’.