bioMérieux Receives Health Canada Approval for the BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel

Montreal (Canada), February 25^th, 2025 – bioMérieux, a world leader in the field of in vitro diagnostics, has achieved a significant milestone with the Health Canada approval of the BIOFIRE^® SPOTFIRE^® Respiratory/Sore Throat (R/ST) Panel. This approval marks a major advancement in the way we approach public health and address today's healthcare challenges associated with respiratory infections and sore throat.

The BIOFIRE^® SPOTFIRE^® R/ST Panel is a unique multiplex PCR¹ test capable of detecting and identifying nucleic acids from up to 15 of the most common bacteria, viruses, and viral subtypes responsible for respiratory infections or sore throat² in about 15 minutes. Samples can be taken from a nasopharyngeal swab when a respiratory tract infection is suspected, or from a throat swab in case of a pharyngitis syndrome.

Colin Hill, General Manager of Clinical Operations, North America, stated: “BIOFIRE^® SPOTFIRE^® exemplifies our dedication to addressing public health challenges. It necessitates a rethinking of healthcare delivery, leveraging advanced diagnostics for swift and informed decision-making. Our priority is to implement impactful solutions that enhance patient care and reduce care disparity. This approval furthers our commitment to bringing innovative solutions even closer to patients.”

The BIOFIRE^® SPOTFIRE^® technology has been especially designed for point-of-care use and is intended to be utilized by non-lab professionals in any clinical setting. This makes BIOFIRE^® SPOTFIRE^® particularly suited for its deployment in the emergency room, intensive care unit, urgent care centers and remote centers where laboratory resources may be limited. When combined with BIOFIRE^® FIREWORKS^®, a centralized data management web portal providing total insights and analytics into performance, utilization, pathogen surveillance, workflow management, BIOFIRE^® SPOTFIRE^® is a powerful and unmatched point-of-care diagnostic solution.

Julie Émond, Vice-President and General Manager of bioMérieux Canada shared: “We are very excited to launch BIOFIRE^® SPOTFIRE^® in Canada, empowering provincial ministries to revolutionize healthcare delivery. Rapid syndromic diagnostics enhance patient workflow, allocate hospital resources more efficiently, reinforce infection prevention and control initiatives, and improve overall patient care. This technology is a significant advancement for addressing care discrepancies in remote areas, ensuring critical decisions are not delayed due to the need for sample transportations.”

¹ Polymerase Chain Reaction

² Under its Health Canada version, the BIOFIRE^® SPOTFIRE^® R/ST Panel is capable of testing:

Viruses: Adenovirus, Coronavirus (seasonal), Human metapneumovirus, Human rhinovirus/enterovirus, Influenza A,

Influenza A subtype H3, Influenza A subtype H1-2009, Influenza B virus, Parainfluenza virus, Respiratory syncytial virus and Coronavirus SARS-CoV-2.

Bacteria: Chlamydia pneumoniae, Mycoplasma pneumoniae,

[Respiratory only]: Bordetella pertussis, Bordetella parapertussis,

[Sore Throat only]: Streptococcus dysgalactiae (group C/G Strep), Streptococcus pyogenes (group A Strep)