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BioMérieux Gets FDA 510(k) Clearance, CLIA Waiver for Respiratory, Throat Infection PCR Test

NEW YORK — French diagnostics firm BioMérieux said Wednesday that it has received 510(k) clearance from the US Food and Drug Administration for its BioFire SpotFire Respiratory/Sore Throat (R/ST) test panel.

The multiplex PCR test, which also received a Clinical Laboratory Improvement Amendments (CLIA) waiver from the FDA, is designed to detect and identify nucleic acids from up to 15 common bacteria, viruses, and viral subtypes responsible for respiratory or sore throat infections in about 15 minutes.

The panel runs on BioMérieux's recently launched SpotFire system for rapid point-of-care molecular diagnostic testing.

"The flexibility of this syndromic panel allows healthcare professionals to test for multiple pathogens with overlapping signs and symptoms, ultimately allowing the diagnostic to drive informed decision-making during the outpatient visit," BioMérieux Chief Medical Officer Charles Cooper said in a statement.

BioMérieux submitted the R/ST panel for the dual 510(k) clearance and CLIA waiver in September and had been predicting FDA action before the end of this year.

BioMérieux also said that it intends to submit the BioFire SpotFire R/ST mini panel, which tests for five viral and bacterial pathogens, for 510(k) clearance and CLIA waiver, but did not provide a timeline.