BioFire respiratory panel obtains FDA Emergency Use Authorization

May 5, 2020

bioMérieux announced that BioFire Diagnostics, its subsidiary specialized in syndromic infectious disease testing, has received Emergency Use Authorization by the U.S. Food and Drug Administration for the BIOFIRE RP2.1 panel, which includes 22 pathogens that cause respiratory infections, including SARS-CoV-2 (the cause of COVID-19 disease).

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 making every effort to scale up supply of the BIOFIRE RP2.1 panel at its production facilities in Salt Lake City (Utah, USA). Test kits will be available for commercial distribution in the USA under EUA, as well as internationally where regulatory approval allows. In a context of 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.

Andrea Kendell, ad interim CEO at BioFire Diagnostics said, “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.”

Kendell further 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.

bioMérieux plans to submit the BIOFIRE RP2.1 panel for FDA de novo clearance.

Outside of the USA, bioMérieux is simultaneously pursuing CE Mark certification for the BIOFIRE Respiratory 2.1plus (RP2.1plus) panel, which also includes detection of MERSCoV, on an accelerated timeline.

The BIOFIRE RP2.1 test is the third molecular test from bioMérieux in response to the COVID-19 pandemic. The ARGENE SARS-CoV-2 R-GENE test and the BIOFIRE COVID-19 test were launched in March.

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