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BioMérieux Seeking FDA 510(k) Clearance for Rapid AST Platform

NEW YORK – BioMérieux said Friday that it is seeking US Food and Drug Administration 510(k) clearance that would allow a US launch of its Vitek Reveal rapid antimicrobial susceptibility testing system to help guide treatment of bacterial sepsis.

The Marcy l'Étoile, France-based firm said the Vitek Reveal delivers clinically useful results for Gram-negative bacteria from positive blood cultures in an average of five-and-a-half hours, providing the opportunity to receive same-day AST results. The panel is CE-IVDD marked and is already sold in Europe.

BioMérieux announced in August that the FDA had granted breakthrough device designation for the test, which the firm predicted would help the company bring rapid care to patients with blood infections. The test was then known as the Specific Reveal Rapid AST System because it had been developed by Specific Diagnostics prior to that firm's acquisition by BioMérieux, which had been distributing Specific Diagnostics' antibiotic susceptibility platform in Europe since 2021.

Pierre Boulud, chief operating officer of clinical operations for BioMérieux, said in the August 2022 announcement that by adding the Reveal system's technology to the firm's portfolio, "we are increasing the ability of laboratories to deliver results in record time, especially in cases of very critical infections such as sepsis which require urgent and appropriate treatment."

BioMérieux has previously said the test system uses metabolomic signature technology in a small-footprint instrument with a targeted menu and modular design. The firm said the system integrates with BioMérieux's comprehensive Sepsis Solution and the Vitek ID/AST brand.