bioMérieux Gains US FDA 510(k) Clearance for VITEK REVEAL AST System

bioMérieux, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its VITEK REVEAL antimicrobial susceptibility testing (AST) System. This system reports results directly from positive blood cultures. 

 

In 2022, bioMérieux acquired Specific Diagnostics, a U.S.-based company that developed the AST system now called VITEK REVEAL. The instrument seamlessly integrates into bioMérieux’s comprehensive portfolio of diagnostic solutions to address bloodstream infections and sepsis.

 

“Based on its unique, patented metabolomic signature technology, the VITEK REVEALTM AST System offers an easy-to-use instrument with a broad antimicrobial coverage, small footprint, and modular design for adaptable throughput, well-suited to address the needs of clinical laboratories,” explained Jennifer Zinn, Executive Vice President, Clinical Operations.

 

The modular VITEK REVEAL AST system can deliver actionable results for gram-negative bacteria directly from positive blood cultures in an average of 5.5-6 hours^4,5 enabling same-day treatment decision-making for patients suffering from bacteremic sepsis.

 

Charles K. Cooper, Executive Vice President, Chief Medical Officer, added, “VITEK REVEALTM is fully aligned with bioMérieux’s priority to provide innovative diagnostics to support antimicrobial stewardship. By integrating this advanced technology in bioMérieux’s portfolio, we are increasing the ability of laboratories to deliver AST results as soon as possible, especially in cases of critical bacteremia-associated sepsis, which require urgent and appropriate treatment.”

 

⁴ Rottman M, Rhodes PA, Singh P, Herrmann JL, Jeannot K, Cattoir V, Carbonnelle E, Plesiat P, Williams A, Dortet L. Clinical evaluation of the SPECIFIC REVEAL™ Rapid AST System with Gram-negative bacteremia samples in 6 hospitals in France and England. Poster presented at: 32nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID); 2022 May; Lisbon, Portugal.

⁵ BMX.1.129899 Clinical Trial Summary Report (proprietary, on file at bioMerieux).