BioMérieux's BioFire SARS-CoV-2 Respiratory Panel Obtains FDA Emergency Use Authorization

BioMérieux’s (Marcy-l'Étoile, France) subsidiary, BioFire Diagnostics, has received Emergency Use Authorization by the US Food and Drug Administration for the BIOFIRE RP2.1 panel, which includes 22 pathogens that cause respiratory infections, including SARS-CoV-2.

The inclusion of SARS-CoV-2 in the BIOFIRE RP2.1 panel allows healthcare providers to quickly identify patients with common respiratory pathogens, as well as those with COVID-19, using one simple test. The BIOFIRE RP2.1 panel takes approximately 45 minutes and tests nasopharyngeal swab samples in transport media. It runs on the fully automated FILMARRAY 2.0 and FILMARRAY TORCH systems and is extremely easy to use.

BioMérieux is currently scaling up supply of the BIOFIRE RP2.1 panel and has made the test kits available for commercial distribution in the USA under EUA as well as internationally where regulatory approval allows. Given the high demand for COVID-19 testing, BioMérieux expects to steadily build inventory levels to address the needs of the thousands of labs and healthcare professionals using one of the nearly 12,000 FILMARRAY systems worldwide.

The BIOFIRE RP2.1 test is the third molecular test from BioMérieux in response to the COVID-19 pandemic, following the launch of the ARGENE SARS-CoV-2 R-GENE test and the BIOFIRE COVID-19 test by the company in March. BioMérieux plans to submit the BIOFIRE RP2.1 panel for FDA de novo clearance. Outside of the US, BioMérieux is simultaneously pursuing CE Mark certification for the BIOFIRE Respiratory 2.1plus (RP2.1plus) panel, which also includes detection of MERS-CoV, on an accelerated timeline. The company has highlighted the need for BioFire’s syndromic approach by pointing out that emerging data suggest patients with COVID-19 may frequently be co-infected with other viruses and/or bacteria.

“The BIOFIRE RP2.1 panel represents our syndromic solution to this unprecedented COVID-19 pandemic. BioFire is dedicated to responding to a rapidly-evolving global epidemiological landscape with urgency and accuracy and this illustrates our contribution to BioMérieux’s public health mission,” said Andrea Kendell, ad interim CEO at BioFire Diagnostics. We believe the syndromic BIOFIRE RP2.1 panel will play a key role now and in the upcoming respiratory season as healthcare providers and patients will likely face the regular group of respiratory pathogens as well as SARS-CoV-2”.

Related Links:
BioMérieux