Syndromic PCR Test Rapidly and Accurately Identifies Pathogens in Patients with Tropical Fever Infections
Posted on 12 Dec 2024
Tropical fevers refer to infections that are common in, or unique to, tropical and subtropical regions. As these diseases spread to previously unaffected areas and can be brought in by travelers, infections such as malaria, chikungunya, dengue, and leptospirosis now affect over 100 countries globally, resulting in more than 316 million cases and 500,000-600,000 deaths annually. The symptoms of tropical fever infections are often vague and overlap, making it difficult to differentiate between mild illnesses that resolve on their own and more serious diseases that require urgent, targeted treatment. Now, a new polymerase chain reaction (PCR) testing solution offers fast and accurate pathogen detection in patients with unexplained fever, thus improving treatment efficiency.
bioMérieux (Marcy-l’Étoile, France) has developed the BIOFIRE® FILMARRAY® Tropical Fever (TF) Panel, which allows healthcare providers to quickly identify pathogens commonly associated with tropical fever infections using a single, easy-to-use test. This panel, which targets six pathogens and has a runtime of approximately 50 minutes, fills a critical gap in tropical fever diagnostics. Notably, the BIOFIRE® FILMARRAY® TF Panel differentiates between Plasmodium falciparum and Plasmodium vivax/ovale, enabling faster and more accurate malaria treatment decisions. The test uses whole blood in Ethylene-diaminetetraacetic acid (EDTA) tubes, with only two minutes of sample preparation time. It runs on the fully automated BIOFIRE® FILMARRAY® 2.0 and BIOFIRE® TORCH Systems.
The BIOFIRE® FILMARRAY® Tropical Fever (TF) Panel has received Special 510(k) clearance from the U.S. Food and Drug Administration (FDA). bioMérieux plans to commercially launch the product in select countries, including the United States, in the first quarter of 2025. The product will also be submitted for CE-marking under the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) prior to its global rollout. Following this, the BIOFIRE® FILMARRAY® TF Panel will be gradually registered and introduced in other countries.
“Thanks to this BIOFIRE® FILMARRAY® Tropical Fever Panel, 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,” said Charles K. Cooper, Executive Vice President, Chief Medical Officer at bioMérieux. “This syndromic test is expected to provide faster and more accurate diagnoses, potentially reducing delays in starting appropriate antimicrobial therapy, preventing complications, and improving patient management and outcomes. The U.S. 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.”
“Tropical fever infections are often complicated to diagnose in a clinically actionable timeframe ― resulting in preventable deaths or unnecessary antibiotic use,” added Jennifer Zinn, Executive Vice President, Clinical Operations at bioMérieux. “Our BIOFIRE® FILMARRAY® Tropical Fever Panel augments bioMérieux’s innovative molecular diagnostics portfolio, providing highly accurate results in less than an hour to aid clinicians in the timely diagnosis of tropical fever infections for optimized therapy decisions. It’s a true game changer for healthcare professionals and their patients, supporting bioMérieux’s global mission to improve public health and preserve antibiotic efficacy.”
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