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BioMérieux Submits Dual FDA Marketing, CLIA Waiver Application for Respiratory, Sore Throat Panel

NEW YORK — French diagnostics maker BioMérieux said on Friday that it has submitted its BioFire SpotFire Respiratory/Sore Throat Panel to the US Food and Drug Administration for a dual 510(k) clearance and CLIA waiver.

The multiplex PCR test is designed to detect 15 of the most common pathogens responsible for respiratory and sore throats including influenza, SARS-CoV-2, and respiratory syncytial virus. The test runs on the FDA-cleared BioFire SpotFire system using either a nasopharyngeal or throat swab with results provided in about 15 minutes. The panel is already CE marked, according to BioMérieux.

Earlier this year, BioMérieux received FDA clearance and CLIA waivers for two other BioFire SpotFire system tests: the BioFire SpotFire Respiratory Panel, which detects 15 pathogens responsible for respiratory tract infections, and the BioFire SpotFire Respiratory Panel Mini, which detects five common viral causes of upper respiratory infections.

"There is a great need for rapid and reliable diagnostic solutions for common infections, particularly in this era of increasing antimicrobial resistance when we need to use antibiotics only when appropriate," BioMérieux Chief Medical Officer and Executive VP Mark Miller said in a statement. "Performing rapid syndromic testing closer to the patient has important medical value."