On May 4, 2020, bioMerieux announced that BioFire Diagnostics, its subsidiary specialized in syndromic infectious disease testing, has received Emergency Use Authorization by the U.S. FDA 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.

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 MERS-CoV, 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. These three complementary tests help meet the varying needs of bioMérieux diverse customers and patients throughout the world. The BIOFIRE® RP2.1 test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories only for the detection and differentiation of nucleic acid of SARS-CoV-2 from multiple respiratory viral and bacterial organisms.