NEW YORK – BioMérieux announced Monday that it has obtained Special 510(k) clearance from the US Food and Drug Administration for a syndromic PCR panel to detect tropical fever pathogens.
The panel can detect the causative agents of fever-causing illnesses — including malaria, chikungunya, dengue, and leptospirosis — which in total result in more than 300 million infections and approximately half a million deaths per year in 100 affected countries.
The overlap in symptoms and epidemiology of different tropical fever infections can make it difficult to distinguish mild illness from severe disease in endemic cases as well as those imported to non-endemic areas by travelers, the firm said in a statement.
"The US FDA Special 510(k) clearance demonstrates BioMérieux’s continued innovative leadership in syndromic testing and our commitment to addressing vital needs in infectious disease diagnostics," said Charles Cooper, executive VP and chief medical officer at BioMérieux. "We address an important diagnostic need to help laboratories, physicians, pediatricians, and traveler clinics faced with these unexplained fevers in endemic and non-endemic regions," Cooper added.
The Tropical Fever Panel detects chikungunya virus, serotypes 1, 2, 3, and 4 of the dengue virus, and Leptospira spp. bacteria. It also detects Plasmodium spp. parasites and differentiates between Plasmodium falciparum and Plasmodium vivax/ovale. The test uses whole blood samples and runs on the firm's BioFire FilmArray 2.0 and high-throughput Torch systems, providing results in approximately one hour following two minutes of sample prep time.
In line with a four-year plan the firm described earlier this year, BioMérieux plans to launch the assay commercially in targeted countries, including the US, in Q1 2025 and will also submit the test for CE-IVDR marking in anticipation of a global launch.
Development of the TF Panel was a joint effort by the US Department of Defense, National Institutes of Health, and BioMérieux's BioFire Defense subsidiary, BioMérieux said.