January 2025—BioMérieux announced that its BioFire FilmArray Tropical Fever panel has received FDA special 510(k) clearance. The panel is capable of testing chikungunya, dengue (serotypes 1, 2, 3, and 4), Leptospira, Plasmodium species, Plasmodium falciparum, and Plasmodium vivax/ovale and has a run time of about 50 minutes on the fully automated BioFire FilmArray 2.0 and Torch systems. Sample prep time is two minutes.
BioMérieux is aiming for a commercial launch in targeted countries, including the United States, in the first quarter of this year.
BioMérieux, 800-682-2666