In vitro diagnostics firm bioMérieux has announced that its BIOFIRE FILMARRAY Tropical Fever (TF) panel has received 510(k) clearance from the US Food and Drug Administration (FDA).
The PCR test enables rapid and accurate identification of pathogens in patients with unexplained fever, helping to optimise overall treatment.
Tropical fevers are defined as infections that are found only in, or prevalent in, tropical and subtropical regions. Because the pathogens spread widely to previously unaffected areas of the world or can be transmitted by travellers, these infections, including for example malaria, chikungunya, dengue fever, and leptospirosis, occur in more than 100 countries worldwide, accounting for more than 316 million cases and causing more than 500,000 to 600,000 deaths each year according to the World Health Organization.
Symptoms of tropical fevers are often non-specific and can be confused with symptoms of other conditions, making it difficult to distinguish between mild, self-limiting illnesses and more serious illnesses that require rapid, targeted treatment. BIOFIRE FILMARRAY Tropical Fever (TF) Panel allows healthcare professionals to rapidly identify the most common pathogens in patients with suspected tropical fever in a single, easy-to-use test.
“With the BIOFIRE FILMARRAY Tropical Fever Panel test, we are addressing a significant diagnostic need to support laboratories, physicians, paediatricians and travel clinics facing these unexplained fevers in endemic and non-endemic regions. This syndromic test can provide faster and more accurate results, with the potential to reduce time to appropriate antibiotic therapy, prevent complications and improve patient monitoring and education. The U.S. FDA 510(k) clearance demonstrates bioMérieux’s leadership and continued innovation in syndromic diagnostics and our commitment to addressing critical infectious disease diagnostic needs,” said Charles K Cooper, Executive Vice President, Medical Affairs, bioMérieux.
The BIOFIRE FILMARRAY TF Panel test is a polymerase chain reaction test that provides rapid pathogen identification from whole blood samples for six targets: chikungunya, dengue (serotypes 1, 2, 3, and 4), Leptospira, and Plasmodium species (P. falciparum and P. vivax/ovale). It has a turnaround time of approximately 50 minutes, with a sample preparation time of only two minutes.
bioMérieux plans to first commercialise the test in a number of countries, including the United States, during the first quarter of 2025. It will then be subject to CE marking under Regulation (EU) 2017/746 (In Vitro Diagnostic Medical Device Regulation - IVDR) for registration and deployment in other countries around the world.