Image created by Dr. Michael J. Miller
The VITEK REVEAL GN AST Assay, developed by BARDA partner bioMérieux, has received FDA 510(k) clearance. This assay, used with the VITEK REVEAL AST System, is designed for antimicrobial susceptibility testing (AST) of Gram-negative bacteria commonly associated with bloodstream infections.
The assay offers a significant advancement by providing results in approximately 5.5 to 6 hours and 75% faster than traditional methods. It employs metabolomic signature technology and Small Molecule Sensors (SMS) to detect bacterial growth and monitor minimum inhibitory concentration (MIC) in real-time, enhancing diagnostic speed and accuracy.
Main Takeaways
- The VITEK REVEAL GN AST Assay has received FDA 510(k) clearance, offering rapid results in about 5.5 to 6 hours with advanced metabolomic signature technology, 75% faster than traditional methods.
- The assay aids in effective antimicrobial stewardship by providing fast, accurate susceptibility results, allowing for informed antibiotic choices and reducing inappropriate use.
- The assay supports BARDA’s strategic goals and aligns with IDSA’s updated guidance by offering susceptibility profiles for resistant pathogens, aiding in the management of complex infections.
This innovation addresses a critical public health concern: Gram-negative bacteria pose a major risk due to rising antibiotic resistance, which can lead to severe conditions such as sepsis. The rapid and precise results from the VITEK REVEAL GN AST Assay support effective antimicrobial stewardship by reducing inappropriate or incorrect antibiotic use. (1)
The assay aligns with BARDA’s 2022-2026 Strategic Plan, which focuses on combating antimicrobial resistance and improving infection control. It contributes to BARDA’s goals by enhancing diagnostic capabilities and supporting effective antibiotic use. (1)
The assay’s quick and accurate results help in making informed decisions about antibiotic therapy. This supports antimicrobial stewardship by reducing the risk of overuse or misuse of antibiotics, as recommended in the IDSA guidance. The assay’s rapid turnaround can help clinicians quickly identify the most effective antibiotics, aligning with IDSA's emphasis on timely and appropriate treatment decisions. (2)
The assay provides detailed susceptibility profiles for complex and resistant pathogens, such as those identified in the IDSA guidance like carbapenem-resistant Enterobacterales, difficult-to-treat Pseudomonas aeruginosa. This assists clinicians in selecting appropriate treatment options, including newer or less commonly used antibiotics. (2)
In addition to this clearance, BARDA has collaborated with BioFire Defense on various contracts, including the development of other diagnostic panels like the BioFire Emerging CoV Panel and the BioFire Emerging Flu Panel. (1)
In summary, the VITEK REVEAL GN AST Assay enhances the management of AMR infections by providing rapid, accurate, and detailed susceptibility testing. This supports effective antimicrobial stewardship, addresses emerging resistance patterns, and aligns with updated clinical guidelines, ultimately improving patient outcomes and infection control.
References
BARDA-Supported Antimicrobial Susceptibility Test (AST) Receives FDA Clearance. August 28, 2024. Accessed September 4, 2024. https://www.medicalcountermeasures.gov/newsroom/2024/vitek
Infectious Diseases Society of America. IDSA 2024 Guidance on the Treatment of Antimicrobial Resistant Gram-Negative Infections. Published Clinical Infectious Diseases July 12, 2024. Accessed September 4, 2024. https://www.idsociety.org/practice-guideline/amr-guidance/