Marcy l’Étoile, France, August 22th 2022 – bioMérieux, a world leader in the field of in vitro diagnostics, today announces that the U.S. Food and Drug Administration (FDA) has granted its Breakthrough Device Designation for the SPECIFIC REVEAL® Rapid Antimicrobial Susceptibility Test (AST) System. This designation is reserved for medical devices that offer significant advantages over existing cleared alternatives, for which no approved alternatives exist, and/or for which device availability is in the best interest of patients1.
The Breakthrough Devices Program aims to provide patients and healthcare professionals with timely access to medical devices of public health interest by expediting their development and assessment and prioritizing their clearance review, while preserving the statutory standards for 510(k) clearance.
SPECIFIC REVEAL® Rapid AST System has been developed by Specific Diagnostics, a U.S. company acquired by bioMérieux in May 2022 (cf. our press release of May 19th).
"I am very pleased to see the SPECIFIC REVEAL® System win this timely recognition," said Paul A. Rhodes, Ph.D., founder and former CEO of Specific Diagnostics. “This will streamline the process for bioMérieux to bring hospitals across the United States a means to more rapid care for patients suffering from blood infections.”
The SPECIFIC REVEAL® Rapid AST System, already on-market under CE-IVD (assay panel) and IVDR (instrument) designation across Europe, provides phenotypic antibiotic susceptibility test results in an average of 5.5 hours2 from availability of a positive blood culture, enabling same-day antibiotic decision-making for patients suffering from bacteremic sepsis, one of the most fast-moving and life-threatening of all medical conditions.
“SPECIFIC REVEAL® is perfectly 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 results in record time, especially in cases of very critical infections such as sepsis, which require urgent and appropriate treatment.” declared Pierre Boulud, Chief Operating Officer, Clinical Operations at bioMérieux.
2 Tibbetts R, et al. Performance of the Reveal Rapid Antibiotic Susceptibility Testing System on Gram-Negative Blood Cultures at a Large Urban Hospital. Journal of Clinical Microbiology, 2022. / Clinical evaluation of the SPECIFIC REVEAL™ with Gram-negative bacteremia samples in 6 hospitals in France and England – 2021.
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