Marcy l’Étoile (France) – bioMérieux, a world leader in the field of in vitro diagnostics, today announced that BioFire Diagnostics, its subsidiary specialized in molecular syndromic infectious disease testing, has received U.S. Food and Drug Administration (FDA) De Novo authorization for the BIOFIRE® RP2.1 Panel.
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.