AST System Delivers Actionable Results for Gram-Negative Bacteria Directly from Positive Blood Cultures

By LabMedica International staff writers
Posted on 29 Jul 2024

Image: The VITEK® REVEAL™ AST System has been granted US FDA 510(k) clearance (Photo courtesy of bioMérieux)

Annually, sepsis claims the lives of 11 million people globally, with 1.3 million of these deaths linked to antibiotic-resistant bacteria. For clinicians, the ability to quickly and accurately interpret antimicrobial susceptibility testing (AST) results is essential to save lives and tailor treatment strategies effectively. Rapid AST not only improves patient outcomes but also reduces the global antimicrobial resistance (AMR) burden by supporting the execution of effective Antimicrobial Stewardship (AMS) programs. Predicting AMR in patients with gram-negative infections is often a more complex and time-consuming process. Early diagnosis and timely treatment are crucial in enhancing outcomes for sepsis patients. Studies have shown that each hour's delay in administering antibiotics significantly increases the likelihood of hospital mortality, even if antibiotics are given within the first six hours. Now, a novel AST system delivers actionable results for gram-negative bacteria directly from positive blood cultures in an average of 5.5-6 hours, enabling same-day treatment decision-making for patients suffering from bacteremic sepsis.

The modular AST system called VITEK® REVEAL™ has been developed by Specific Diagnostics (Mountain View, CA, USA), a company acquired by bioMérieux (Marcy l’Étoile, France) in 2022 as part of its commitment to combat sepsis and AMR. VITEK® REVEAL™ offers extensive antimicrobial coverage for gram-negative bloodstream infections delivering phenotypic AST results in an average of 5.5 hours directly from positive blood culture to better manage bloodstream infections. The instrument seamlessly integrates into bioMérieux’s unique and comprehensive portfolio of diagnostic solutions to address bloodstream infections and sepsis. With the addition of VITEK® REVEAL™, bioMérieux’s comprehensive Sepsis Solution helps manage patient’s antibiotic therapy, bringing rapid and reliable results to support clinical decisions for better patient care.

The VITEK® REVEAL™ AST System has received U.S. Food and Drug Administration (FDA) 510(k) clearance, allowing its commercialization in the United States. In August 2022, the FDA granted the system with its Breakthrough Device Designation, which 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 patients. This AST system is also CE-marked under IVDD (reagents) and IVDR (instrument) in Europe.

“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, Executive Vice President, Clinical Operations.

“VITEK® REVEAL™ is fully aligned with bioMérieux’s priority to provide innovative diagnostics to support antimicrobial stewardship,” added Dr. Charles K. Cooper, Executive Vice President, Chief Medical Officer. “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.”