News24 March, 2020
bioMérieux, a world leader in the field of in vitro diagnostics, today announced that its subsidiary, BioFire Defense, has received Emergency Use Authorization by the U.S. Food and Drug Administration of its BIOFIRE® COVID-19 test for use in CLIA moderate and high complexity clinical...
bioMérieux announces the expansion of the CE marking of its molecular biology ARGENE® SARS-CoV-2 diagnostic test to include saliva specimens.
Marcy l’Etoile, France – November 16, 2020 – bioMérieux, a world leader in the field of in vitro diagnostics, has announced the expansion of its ARGENE® range for the detection of SARS-CoV-2. As a complement to nasopharyngeal swab specimens, the singleplex SARS-CoV-2 R-GENE® real-time PCR test may now be used on saliva and oropharyngeal (throat) swab specimens for the detection of the virus that causes COVID-19. This development helps optimize laboratory workflows.
bioMérieux, a world leader in the field of in vitro diagnostics, announces that BioFire Diagnostics, its molecular biology affiliate, has submitted to the Food and Drug Administration for 510(k) clearance of the BIOFIRE® Blood Culture Identification 2 (BCID2) Panel. The BIOFIRE® BCID2 Panel includes several additional pathogens, an expanded list of antimicrobial resistance genes, and many revised targets compared to the existing BIOFIRE® BCID Panel.d about 9,800.