bioMérieux Receives CE Mark for Two New Rapid PCR Tests
bioMérieux has announced the acquisition of the CE mark under the IVDR directive for two diagnostic tests for respiratory and pharyngeal infections. These multiplex PCR tests, compatible with bedside use, are now authorized in Europe for deployment outside of traditional laboratories.
Introduction of Advanced Diagnostic Panels
The BIOFIRE® SPOTFIRE® Respiratory/Sore Throat plus (R/STplus) Panel and BIOFIRE® SPOTFIRE® R/STplus Panel Mini have received the CE mark under the IVDR, including the 'Near-Patient Testing' classification allowing use at the point of care. These multiplex PCR tests can simultaneously detect pathogens responsible for respiratory infections and sore throats in about 15 minutes. The standard panel detects 15 pathogens, while the Mini panel identifies 6, including human rhinovirus/enterovirus, Streptococcus A, influenza A/B viruses, RSV, and SARS-CoV-2. Samples can be taken using nasopharyngeal, oropharyngeal swabs, or, for the Mini panel, anterior nasal swabs.
Enhancement of Respiratory Diagnostic Offerings
The BIOFIRE® SPOTFIRE® R/STplus Panel replaces the previous version marketed with the CE mark under the IVDD directive. bioMérieux is simultaneously introducing the R/STplus Panel Mini, enhancing its respiratory diagnostic offerings in Europe. Both tests will be available in the second quarter of 2026 in countries recognizing the CE mark, and will then be deployed in other regions outside the United States according to local regulations.
