BioMérieux Point-of-Care System, Respiratory Panel Get FDA 510(k) Clearance, CLIA Waiver
The BioMérieux BioFire Spotfire Respiratory Panel was reviewed through the FDA's dual 510(k)/CLIA waiver pathway, making it the first COVID-19 test to be cleared with a CLIA waiver.
Sanger Institute-led Respiratory and Microbiome Initiative to Develop Genomic Surveillance Methods
The initiative will expand on the expertise gained through the use of genomic sequencing during the ongoing COVID-19 pandemic, applying it to other respiratory pathogens.
Helix Wins $5M CDC Contract for Pan-Respiratory Viral Surveillance Program
Under the program, the firm will identify and track more than 30 respiratory viral variants in collaboration with two large healthcare centers.
At the AMP annual meeting this week, the company outlined its technology and vision for a speedy, low-cost, high-accuracy diagnostic.
Curetis to Assist BioVersys' Antibacterial Drug Trial With Unyvero Platform
BioVersys will use the Unyvero HPN in its drug trial to test hospitalized trial candidates for antibiotic-resistant Acinetobacter infections.