Skip to main content
Premium Trial:

Request an Annual Quote

FDA Clears BioMérieux Vitek Reveal Antimicrobial Susceptibility Testing System

NEW YORK – BioMérieux announced Friday that the US Food and Drug Administration has granted 510(k) clearance to its Vitek Reveal system and an assay to determine antimicrobial susceptibility of Gram-negative bacteria directly from positive blood cultures.

The modular system can be used to more quickly provide tailored sepsis treatments, the firm said in a statement, delivering results in approximately six hours.

"Based on its unique, patented metabolomic signature technology, the Vitek Reveal 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," said Jennifer Zinn, BioMérieux's executive VP of clinical operations.

BioMérieux acquired the core technology of the Reveal in April 2022 with the purchase of Specific Diagnostics. The CE-marked system was granted breakthrough device designation by the FDA in August of that year and was submitted to the FDA in 2023.

In its five-year plan disclosed in April, BioMérieux said it will add a Gram-negative blood culture test to the Vitek Reveal in 2027. The firm also previously said that it expects the Vitek Reveal to reinforce its position in AST and to generate more than $60 million in annual sales by 2027.