On Mar. 11, 2020, bioMerieux announced the forthcoming launch of 3 different tests to address the COVID-19 epidemic and to meet the different needs of physicians and health authorities in the fight against this emerging infectious disease. bioMerieux had finalized the development of the SARS-COV-2 R-GENE test. This real-time PCR test is clinically validated on one type of respiratory specimen and will be available at the end of March.

In parallel, a fully-automated test based on the BIOFIRE® FILMARRAY® technology is being developed with the support of the US Department of Defense. This test will specifically detect SARS-CoV-2 and is designed to run on FILMARRAY® 2.0 and FILMARRAY® TORCH platforms.

bioMérieux is also developing an expanded version of its BIOFIRE® FILMARRAY® Respiratory Panel 2, which will be called the BIOFIRE® Respiratory Panel 2.1 (RP2.1). This new panel will include SARS-CoV-2 in addition to the 21 other common respiratory pathogens and will deliver results in approximately 45 minutes. It will also be available on the FILMARRAY® 2.0 and FILMARRAY® TORCH platforms.

These two BIOFIRE® tests will be submitted to relevant regulatory authorities in Q2 and Q3 2020 respectively, their launch will follow immediately after regulatory authorization or clearance.

The ARGENE® SARS-COV-2 R-GENE® tests will be produced in Verniolle (France), the BIOFIRE® SARS-CoV-2 and BIOFIRE® RP2.1 tests in Salt Lake City (USA). Both production sites benefit from an extensive expertise in the manufacturing of molecular biology reagents at industrial scale.