BIOMÉRIEUX CANADA RECEIVES HEALTH CANADA APPROVAL FOR ITS BIOFIRE^® JOINT INFECTION (JI) PANEL  

Montréal, Canada – 28-08-2023 – bioMérieux, a world leader in the field of in vitro diagnostics, today announces that its BIOFIRE^® Joint Infection (JI) Panel has received Health Canada Approval. This panel rapidly tests for 31 pathogens commonly associated with joint infections and 8 antimicrobial resistance (AMR) genes, optimizing timely antibiotic therapy and stewardship. Joint infections are devastating and can occur at all ages, leading to functional joint impairment, long-lasting disability, and may even be life-threatening. In Canada, it is estimated that 30% of hip and knee revisions may be attributed to infection[1]. With an incidence of 2 per 100,000 people, septic arthritis is most commonly seen in young children and the elderly[2]. Its diagnosis is particularly challenging as signs and symptoms may be non-specific and multiple diagnostic techniques are often required[3].

Optimal treatment of joint infections depends on a rapid and accurate diagnosis. In fact, joints can suffer substantial damage if the infection is not adequately and promptly treated[4]. However, its diagnosis remains challenging as the available diagnostic methods have variable accuracy, may have long turnaround times, and may be negatively impacted by prior antimicrobial therapy use.

Dr. Marisa Azad , MD/ PhD, The Ottawa Hospital, adds: “The diagnosis of joint infections in adults and children can be challenging and often require a combination of different diagnostic modalities. The key to effective treatment and improving patient outcomes is to rapidly achieve an accurate diagnosis. This new panel addresses gaps in the diagnostic workup: prolonged turn-around-times, the problem of culture-negative results, and a lack of standardization in diagnostic criteria – particularly with periprosthetic joint infection. Molecular diagnostics in orthopedic infections is an exciting new area and the BIOFIRE^® JI panel has the potential to offer a more rapid diagnosis and targeted antimicrobial therapy for these patients."

The BIOFIRE^® Joint Infection Panel is the newest syndromic panel to the BIOFIRE^® family. 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, including more informed decision-making for pathogen-guided patient management, surgical-related decision and antibiotic therapy, supporting 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.

Julie Émond, Vice-President and General Manager, said: “Joint Infection can have severe and long lasting dysfunction and disabilities - conditions that can now be mitigated with rapid and accurate diagnosis, and access to appropriate treatment through the novel BIOFIRE^® Joint Infection syndromic panel[5]. This really fills a diagnostic gap in the detection of Kingella Kingae, a common organism found in paediatric sample, often missed in near in 2/3 of routine cultures[6]. It is really a game changer for pediatric patients affected by join infection.”

Thanks to the new BIOFIRE^® Joint Infection Panel, we are able to expand the clinical value of BIOFIRE^® to a new disease state along with 4 other syndromes covered by the BIOFIRE^® menu, with an innovative diagnostic solution that directly addresses the laboratory’s and clinicians’ needs: comprehensive, fast and reliable diagnosis. It reinforces bioMérieux’s leadership role in syndromic testing with the widest portfolio of diagnostic solutions available today in Canada, addressing vital needs in infectious disease diagnostics, in and outside the laboratory.

ABOUT BIOFIRE^® FILMARRAY^®

The BIOFIRE^® solution is a Health Canada, U.S. FDA-cleared and CE-marked closed multiplex PCR and fully automated system that integrates sample preparation, amplification, and detection. A BIOFIRE^® test requires only two minutes of hands-on time and has a total run time in as little as 45 minutes, depending on the panel. The BIOFIRE^® range has the largest infectious disease pathogen menu commercially available. It is composed panels covering 5 syndromes

• BIOFIRE^® Respiratory Panel (RP2.1), identifying 22 respiratory viruses and bacteria performed directly on nasopharyngeal swabs in transport media.
• BIOFIRE^® Blood Culture Identification 2 (BCID2), identifying 43 of the most common causes of bloodstream infections and associated antimicrobial resistance directly from positive blood culture.
• BIOFIRE^® Gastrointestinal (GI) Panel, identifying 22 of the most common viral, bacterial, and parasitic causes of infectious diarrhea directly from stool in Cary Blair transport media.
• BIOFIRE^® Meningitis/Encephalitis (ME) Panel, identifying 14 bacterial, viral, and fungal causes of meningitis and encephalitis directly from cerebrospinal fluid.
• BIOFIRE^® Joint Infection (JI) Panel, identifying 31 common causes of joint infections and 8 antimicrobial resistance genes directly from synovial fluid.