bioMérieux receives IVDR CE marking for two BIOFIRE SPOTFIRE Panels
20 Mar 2026
bioMérieux has announced that its BIOFIRE® SPOTFIRE® Respiratory/Sore Throat plus (R/STplus) Panel and BIOFIRE® SPOTFIRE® Respiratory/Sore Throat plus (R/STplus) Panel Mini have been CE-marked under the In Vitro Diagnostic Regulation.
The certification includes conformity assessment for near-patient testing, enabling its use outside traditional laboratories, directly at the point of care. These multiplex PCR tests can simultaneously detect the most common pathogens responsible for respiratory and sore throat infections, within a timeframe aligned with a typical patient visit.
Compatible with the compact innovative BIOFIRE® SPOTFIRE® System, the BIOFIRE® SPOTFIRE® R/STplus Panel and the BIOFIRE® SPOTFIRE® R/STplus Panel Mini are unique multiplex PCR tests capable of identifying nucleic acids for the most common bacteria, viruses, and viral subtypes responsible for respiratory or sore throat infections, in about 15 minutes.
The BIOFIRE® SPOTFIRE® R/STplus Panel detects 15 pathogens and the BIOFIRE® SPOTFIRE® R/STplus Panel Mini detects up to 6 pathogens, including human Rhinovirus/Enterovirus, Strep A, Flu A/B, RSV and SARS-CoV-2. Together, these assays deliver a flexible and tailored solution that empowers clinicians to choose the right test on a single streamlined platform that combines clinical flexibility with operational simplicity.
The BIOFIRE® SPOTFIRE® R/STplus Panel is intended to replace the previously commercialized BIOFIRE® SPOTFIRE® R/ST Panel, which was CE-marked under the In Vitro Diagnostic Directive, as the product transitions to its new registration under IVDR. In addition, bioMérieux is introducing the BIOFIRE® SPOTFIRE® R/STplus Panel Mini, further strengthening its dynamic and contextual respiratory testing approach in Europe.
Samples may be collected using either a nasopharyngeal or a throat swab, depending on the suspected infection. The BIOFIRE® SPOTFIRE® R/STplus Panel Mini also offers a third sampling method with anterior nasal swab specifically for use with the respiratory menu. Flexibility in sample types facilitates testing in non-traditional locations.
“The IVDR CE-marking certification of these two R/ST panels is an important milestone for bioMérieux ― strengthening our ability to support healthcare professionals with flexible, cost-effective point-of-care testing solutions across Europe. With proven commercial performance and a rapidly expanding menu, BIOFIRE® SPOTFIRE® is a testament of bioMérieux’s leadership and commitment to diagnostic innovation for improved patient outcomes,” said Jennifer Zinn, Executive Vice President, Clinical Operations, bioMérieux.