May 9, 2022—BioMérieux’s BioFire joint infection panel has received FDA de novo authorization. The panel uses synovial fluid samples obtained directly from the affected joint and tests for 31 pathogens and eight antimicrobial resistance genes. It runs on the fully automated BioFire FilmArray 2.0 and Torch systems with two minutes of sample preparation time and results are provided in about one hour
The company says it is planning a commercial launch in the United States within the next two months and will gradually deploy and register the panel in other countries, including submitting it for CE marking under the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746.