bioMérieux receives De Novo FDA Authorization for its BIOFIRE® Joint Infection (JI) Panel04 May, 2022
Marcy l’Étoile, France - bioMérieux, a world leader in the field of in vitro diagnostics, today announces that its BIOFIRE® Joint Infection (JI) Panel has received De Novo authorization from the US Food and Drug Administration (FDA). This panel tests for 31 pathogens implicated in most acute joint infections, and also includes 8 antimicrobial resistance (AMR) genes to optimize antibiotic therapy and stewardship.
Joint infections (“septic arthritis”) are serious infections involving either native or prosthetic joints. They are medical emergencies which can occur at all ages, and can lead to functional joint impairment, long-lasting disability, and may even be life-threatening. The number of prosthetic joint infections is rising globally as the number of joint replacements increases.
Optimal treatment of joint infections depends on a rapid and accurate diagnosis. However, the diagnosis of joint infections remains challenging as the available diagnostic methods have variable accuracy, may have long turnaround times, and are often negatively impacted by prior antimicrobial therapy.
The BIOFIRE® Joint Infection Panel is the newest syndromic panel intended to aid in the diagnosis of the specific agents causing joint infections.
The BIOFIRE® JI Panel allows healthcare providers to quickly identify pathogens commonly found in patients presenting with suspected joint infections, along with AMR genes to optimally guide antibiotic therapy, all in one simple rapid test.
With a rapid turnaround time of about 1 hour and a broad panel menu of 39 targets, the BIOFIRE® JI Panel addresses unmet needs in joint infection diagnostics. Through fast and accurate results, the BIOFIRE® JI Panel may provide more informed decision-making for pathogen-guided management of patients with joint infections. It may also help guide surgical and antibiotic decision-making, thus aiding in Antimicrobial Stewardship (AMS).
The BIOFIRE® JI Panel provides results using synovial fluid samples obtained directly from the affected joint. It runs on the fully automated BIOFIRE® FILMARRAY® 2.0 and BIOFIRE® Torch Systems with only 2 minutes of sample preparation time.
bioMérieux is targeting a commercial launch in the US within the next two months, and then the BIOFIRE® JI Panel will be gradually registered and deployed in other countries, including those that recognize FDA authorization. It will be submitted for CE-marking under the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) in the coming weeks.
Pierre Boulud, Chief Operating Officer, Clinical Operations, said: “The BIOFIRE® Joint Infection Panel expands bioMerieux’s syndromic offering to a new disease state in addition to the 5 other syndromes covered by the BIOFIRE® menu, making it the broadest menu of highly multiplex syndromic panels in existence and available to the labs today. Thanks to this panel, we address an important diagnostic need to help Emergency Department and Infectious Disease physicians, pediatricians, and also orthopedic surgeons faced with these important joint infections. This De Novo authorization demonstrates bioMerieux’s continued innovative leadership in molecular syndromic testing and our commitment to addressing vital needs in infectious disease diagnostics.”
Mark Miller, Chief Medical Officer, stated: “The BIOFIRE® Joint Infection Panel should provide clinicians with a faster and more accurate diagnosis, thus potentially reducing the delay to initiate appropriate antimicrobial therapy, speeding up surgical decision-making, and improving overall management to benefit patients and improve outcomes.”