bioMerieux climbs more than 3% and goes back above 80 euros this Wednesday, while the group announced the coming launch of 3 tests aimed at responding to the COVID-19 epidemic and meeting the different needs of clinicians and health authorities in the fight against this new infectious disease.
bioMerieux has finalized the development of the SARS-COV-2 R-GENE test.
“The company had announced the development of a test to address the Covid-19 epidemic, and this announcement shows that it is progressing faster than expected. The company’s global anchoring, particularly in China, will be an important asset in the face of the many other competing tests “comments Portzamparc who keeps the file.
This real-time PCR test has been clinically validated on a type of respiratory sample and will be available from the end of March. It should quickly benefit from a CE marking and will be the subject of a request for authorization of use in emergency (EUA-Emergency Use Authorization) near the American Food and Drug Administration.
In parallel, a new fully automated test using BIOFIRE FILMARRAY technology is being developed with the support of the United States Department of Defense.
This test will specifically detect SARS-CoV-2 and can be used on the FILMARRAY 2.0 and FILMARRAY TORCH platforms.
bioMerieux is also developing a new extended version of its BIOFIRE FILMARRAY (RP2) 2 respiratory panel: the BIOFIRE RP2.1 panel. This new panel will integrate SARS-CoV-2 in addition to the 21 pathogens most frequently responsible for respiratory infections that it can already detect, in around 45 minutes. It will also be available on the FILMARRAY 2.0 and FILMARRAY TORCH platforms.
These two BIOFIRE tests will be submitted to the competent regulatory authorities in the 2nd and 3rd quarters of 2020 respectively, their launching will take place immediately after obtaining the marketing authorizations.
“Faced with the urgency of the COVID-19 epidemic, bioMerieux is committed to offering a complete diagnostic solution that meets the highest performance and quality requirements, in order to help clinicians effectively combat this epidemic, “said Mark Miller, physician and Executive Director, Medical Affairs for bioMerieux.
The ARGENE SARS-COV-2 R-GENE tests will be produced in Verniolle (France) and the BIOFIRE SARS-CoV-2 and BIOFIRE RP2.1 tests in Salt Lake City (United States). These production sites benefit from a great expertise in the manufacturing of molecular biology reagents on an industrial scale …