BioFire claimed that its RP 2.1 is the first Covid-19 diagnostic test to receive marketing authorisation under De Novo review pathway
BioFire Diagnostics has secured the US Food and Drug Administration (FDA) marketing authorisation for its BioFire Respiratory Panel 2.1 (RP2.1) diagnostic test.
RP2.1 uses nasopharyngeal swabs (NPS) for the simultaneous detection and identification of 22 different viral and bacterial pathogens causing respiratory infections, including SARS-CoV-2.
The company said that its RP2.1 panel is the first SARS-CoV-2 diagnostic test to receive FDA De Novo status, despite being reviewed through the normal pathway.
Also, the current De Novo authorisation by the FDA revokes the previous EUA for the device, granted in May last year.
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 authorized for marketing under our traditional premarket authorities.
“While this is the first marketing authorisation 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 company’s De Novo application was backed by a multicentre clinical study, which evaluated the performance of RP2.1 panel, compared to three independent molecular SARS-CoV-2 tests with FDA EUA.
The clinical trial in more than 500 specimens showed that the test was safe and effective in the identification and differentiation of various respiratory viral and bacterial pathogens.
Also, the test demonstrated 98.4% positive percent agreement (PPA) and 98.9% negative percent agreement (NPA), said the company.
Furthermore, the FDA De Novo request for the test is also based on additional data showing validation, which is more than required for the emergency use authorisation.
BioFire Diagnostics is focused on molecular syndromic infectious disease testing and is a subsidiary of bioMérieux, an in vitro diagnostics company.
BioMérieux clinical operations chief operating officer Pierre Boulud said: “The De Novo authorisation of the BioFire RP2.1 Panel demonstrates how BioFire is dedicated to responding to a rapidly-evolving global pandemic with urgency and accuracy. This is the first U.S. FDA De Novo authorised Covid-19 test.”