BioMérieux announces that it has received 510(k) clearance and CLIA (Clinical Laboratory Improvement Amendments) waiver from the US Food and Drug Administration (FDA) for its innovative Biofire Spotfire Respiratory/Sore Throat (R/ST) rapid test range.

BioMérieux reports that its solution is a unique multiplex PCR test capable of detecting and identifying, in around 15 minutes, nucleic acids from 15 of the bacteria, viruses and viral subtypes most commonly responsible for respiratory or pharyngeal infections.

Samples can be obtained by nasopharyngeal or oropharyngeal swab.

This test 'allows clinicians to search for multiple pathogens with identical signs and symptoms in patients, ultimately enabling informed decisions to be made during the outpatient consultation. These results help to advance the proper use of antibiotics and modernize patient care," commented Dr. Charles K. Cooper, Executive Vice President, Medical Affairs, bioMérieux.


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