The company finalised the development of a real-time PCR test, SARS-COV-2 R-GENE. Claimed to be clinically validated on one type of respiratory specimen, the test should be available by the end of this month.
BioMérieux states that the SARS-COV-2 R-GENE has been submitted to the FDA for an Emergency Use Authorisation, while also expected to obtain CE Mark in Europe.
The company is also simultaneously developing a fully-automated test based on the BIOFIRE FILMARRAY technology with the support of the US Department of Defense.
This test runs on FILMARRAY 2.0 and FILMARRAY TORCH platforms, intended to detect SARS-CoV-2.
BioMérieux is also developing BIOFIRE Respiratory Panel 2.1 (RP2.1), an expanded version of its BIOFIRE FILMARRAY Respiratory Panel 2.
The panel will detect SARS-CoV-2 in addition to the 21 other common respiratory pathogens, claimed to deliver results in approximately 45 minutes.
The test will be available on the FILMARRAY 2.0 and FILMARRAY TORCH platform.
The two BIOFIRE tests will be submitted to relevant regulatory authorities in Q2 and Q3 2020, respectively.
The company expects to launch these tests immediately after regulatory authorisation or clearance.
BioMérieux executive vice president and chief medical officer Mark Miller said: “In the face of the urgency of the COVID-19 epidemic, bioMérieux is committed to providing a comprehensive diagnostic approach that meets the highest performance and quality standards to help physicians mount an effective response to the outbreak.”
ARGENE SARS-COV-2 R-GENE tests will be produced in Verniolle in France, while BIOFIRE SARS-CoV-2 and BIOFIRE RP2.1 tests are being developed in the US.