It will be submitted for CE-marking under the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) in the coming weeks. It runs on the fully automated BIOFIRE ® FILMARRAY ® 2.0 and BIOFIRE ® Torch Systems with only 2 minutes of sample preparation time.īioMérieux 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. The BIOFIRE ® JI Panel provides results using synovial fluid samples obtained directly from the affected joint. It may also help guide surgical and antibiotic decision-making, thus aiding in Antimicrobial Stewardship (AMS). Through fast and accurate results, the BIOFIRE ® JI Panel may provide more informed decision-making for pathogen-guided management of patients with joint infections. 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. 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. The BIOFIRE ® Joint Infection Panel is the newest syndromic panel intended to aid in the diagnosis of the specific agents causing joint infections. 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. Optimal treatment of joint infections depends on a rapid and accurate diagnosis. The number of prosthetic joint infections is rising globally as the number of joint replacements increases. 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. Joint infections (“septic arthritis”) are serious infections involving either native or prosthetic joints. 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. Using PCR technology, the BIOFIRE JI Panel offers a rapid sample-to-answer turnaround without sacrificing performance.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). The BIOFIRE JI Panel is a rapid syndromic test that delivers comprehensive results in one easy-to-read report. It is not impacted by prior antibiotic use and targets difficult-to-grow anaerobes and fastidious organisms.Ĭompared to conventional methods, it can help facilitate increased diagnostic yield and improved polymicrobial detectionīIOFIRE JI Panel targets Gram-Positive BacteriaĬonventional testing for joint infections is complex, often requiring multiple patient samples, various send-out tests, and days of waiting for results. The BIOFIRE JI Panel identifies 39 pathogens and antimicrobial resistance markers at the molecular level, encompassing the common causes of joint infections. Taken together, the six BIOFIRE ® panels comprise the largest infectious disease pathogen menu commercially available. The BIOFIRE ® JI Panel is one of six FDA-cleared and/or CE-marked panels for use on the BIOFIRE ® multiplex PCR system. Broad Panel Menu: Simultaneously tests for 39 targets.The BIOFIRE ® Joint Infection (JI) Panel tests for a comprehensive grouping of 29 gram-positive and gram-negative bacteria, 2 yeast, and 8 antimicrobial resistance genes commonly associated with joint infections. Simple, comprehensive joint infection testing
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