The U.S. Food and Drug Administration (FDA) has granted special 510(k) clearance to BioMérieux's syndromic tropical fever panel, developed in conjunction with U.S. government agencies.
The Biofire Filmarray Tropical Fever Panel is a syndromic polymerase chain reaction test that provides rapid pathogen identification for six targets: chikungunya, dengue (serotypes 1, 2, 3, and 4), Leptospira, and Plasmodium species (Plasmodium falciparum and Plasmodium vivax/ovale). It uses whole-blood samples and runs on the fully automated Biofire Filmarray 2.0 and Biofire Torch Systems with only two minutes of sample preparation time, BioMérieux said in a statement.
The panel was created as a project of BioFire Defense, a BioMérieux-owned U.S. subsidiary, with the U.S. Department of Defense, and the U.S. National Institutes of Health.
The symptoms of tropical fever infections are often nonspecific and overlapping, and the diseases may be mild and self-limiting or severe and require prompt treatment. The panel allows healthcare providers to quickly identify the pathogens responsible for common tropical fever infections.
BioMérieux said that it is aiming for a commercial launch in certain countries, including the U.S., in the first quarter of 2025. Additionally, the Biofire panel will be submitted for CE marking under the European Union's In Vitro Diagnostic Medical Devices Regulation. The panel will subsequently be registered and launched in other countries, the firm added.
