French diagnostics company bioMérieux (Euronext Paris:BIM) said on Thursday that it has obtained IVDR CE marking for its BIOFIRE SPOTFIRE Respiratory/Sore Throat plus (R/STplus) Panel and Panel Mini, enabling near-patient diagnostic use across Europe.

This certification allows deployment outside traditional laboratories, supporting point-of-care testing during routine patient visits.

The multiplex PCR panels are designed to detect common respiratory and sore throat pathogens within approximately 15 minutes, addressing the need for rapid and accurate diagnosis amid overlapping symptoms. The standard panel identifies 15 pathogens, while the Mini version detects up to six, including Rhinovirus/Enterovirus, Strep A, Flu A/B, RSV, and SARS-CoV-2.

Both assays operate on the BIOFIRE SPOTFIRE system and support multiple sample collection methods, including nasopharyngeal, throat, and anterior nasal swabs. The new panels will replace earlier IVDD-certified versions and expand bioMérieux's point-of-care testing portfolio with flexible, cost-effective solutions.

The products are scheduled for availability in the second quarter of 2026 in CE-recognising countries, with further international rollout subject to local regulatory approvals.