BIOFIRE FILMARRAY Tropical Fever Panel receives US FDA Special 510(k) clearance
Tropical Fever Panel a syndromic PCR test, targets the causes of tropical fever infections
13 Dec 2024
bioMérieux, a world leader in the field of in vitro diagnostics, has announced that its BIOFIRE® FILMARRAY® Tropical Fever (TF) Panel has received U.S. Food and Drug Administration (FDA) Special 510(k) clearance. This innovative polymerase-chain reaction (PCR) testing solution offers fast and accurate pathogen identification in patients with unexplained fever, helping to optimize treatment overall.
Presentation of tropical fever infections are often non-specific and overlapping, complicating efforts to distinguish mild self-limiting illness from more severe diseases that require prompt and targeted treatment. The BIOFIRE® FILMARRAY® Tropical Fever (TF) Panel allows healthcare providers to quickly identify pathogens commonly found in patients presenting with suspected tropical fever infections in one fast easy-to-use test.
The BIOFIRE® FILMARRAY® TF Panel, that has six targets* and a run time of about 50 minutes, addresses unmet needs in tropical fever diagnostics. This innovative panel speciates between Plasmodium falciparum and Plasmodium vivax/ovale which may help healthcare providers target appropriate malaria treatment faster.
The BIOFIRE® FILMARRAY® TF Panel provides results using whole blood in ethylene-diaminetetraacetic acid (EDTA) tubes. It runs on the fully automated BIOFIRE® FILMARRAY® 2.0 and BIOFIRE® TORCH Systems with only two minutes of sample preparation time.
bioMérieux is aiming for a commercial launch in targeted countries, including the United States, in the first quarter of 2025. It will be submitted for CE-marking under the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) prior to the global launch. The BIOFIRE® FILMARRAY® TF Panel will then be gradually registered and deployed in additional countries.
Development of the BIOFIRE® FILMARRAY® TF Panel was a joint effort by the U.S. Department of Defense (DoD), National Institutes of Health (NIH), and BioFire Defense, a bioMerieux-owned U.S. subsidiary.
*The BIOFIRE® FILMARRAY® Tropical Fever (TF) Panel is capable of testing: chikungunya, dengue (serotypes 1, 2, 3, & 4), Leptospira, Plasmodium species, Plasmodium falciparum, Plasmodium vivax/ovale.
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