Marcy l’Étoile, France, April 12th 2022 – bioMérieux, a world leader in the field of in vitro diagnostics, announces that it has entered into an agreement to acquire Specific Diagnostics, a privately held U.S. based company that has developed a rapid antimicrobial susceptibility test (AST) system that delivers phenotypic AST directly from positive blood cultures. bioMérieux has held a minority stake in Specific Diagnostics since 2019, and the two companies had signed a co-distribution agreement covering the European market in 2021.
bioMérieux receives FDA 510(k) clearance for its VITEK® MS PRIME new MALDI-TOF mass spectrometry identification system
Marcy l’Etoile, France – March 18, 2022 — bioMérieux, a world leader in the field of in vitro diagnostics, announces that VITEK® MS PRIME, its new MALDI-TOF1 mass spectrometry identification system, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This next generation system for routine microbial identification in minutes is now commercially available in countries that recognize CE-marking and in the United States.
As the incidence of infections with the SARS-CoV-2 Omicron variant (B.1.1. 529) continues to rise, there is much concern about diagnostic tests ability to efficiently detect this multi-mutated form of the COVID-19 virus.
bioMérieux announces CE-marking of the new MALDI-TOF mass spectrometry identification system: VITEK® MS PRIME
bioMérieux, a world leader in the field of in vitro diagnostics, has announced the CE-marking of VITEK® MS PRIME, the next generation of the VITEK® MS MALDI-TOF1 mass spectrometry system for routine microbial identification in minutes.
bioMérieux, a world leader in the field of in vitro diagnostics, today releases its business review for the three months ended March 31, 2021.
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.