Specific Reveal Rapid AST Study with the Henry Ford Health System in Detroit to be Published in the Journal of Clinical Microbiology
Specific Diagnostics today announces acceptance and publication of a peer-reviewed manuscript reporting the performance of the Reveal Rapid Antibiotic Susceptibility Testing (AST) system for blood infection samples, let by co-authors Drs. Linoj Samuel and Robert Tibbetts at the Henry Ford Health System in Detroit, Michigan.
The study, titled “Performance of the Reveal rapid AST system on Gram-negative blood cultures at a large urban hospital” assessed the performance of Reveal compared to VITEK 2 and Sensititre, and reported 98.0% Essential Agreement, 96.4% Categorical Agreement, just 1.3% very major error, and a less than 5 hour time-to-result, averaged across all 104 strains and 24 antibiotics tested.
“The Specific Reveal instrument showed comparable performance with standard of care AST methods while delivering results in a much shorter time frame. The system was relatively easy to use with less than 3 minutes of hands on time. The ability to deliver AST results quickly without compromising on the quality of results is critical to improving the quality of patient care” said Dr. Samuel, Division Head, Clinical Microbiology at Henry Ford Health System.
“We’ve performed preclinical work with Reveal for over two years now,” agreed Dr. Robert Tibbetts, Associate Clinical Microbiology Director at Henry Ford, “and our team has been very pleased with its performance and ease-of-use. Antimicrobial stewardship in the form of rapid escalation or de-escalation of appropriate antimicrobial therapy is crucial to circumvent the current rise in resistant bacteria, and rapid and reliable susceptibility results will go a long way to facilitate this. We are pleased to have performed the first preclinical validation of this potentially important new system.”
“We have very much valued the clinical partnership we have had with Drs. Samuel and Tibbetts and their laboratory team at Henry Ford,” said Dr. Paul Rhodes, CEO of Specific. “This highly successful preclinical validation was performed with the very first Reveal instruments we produced, and now there are well over 100 deployed in Europe under CE-IVD as well as on an RUO basis in the US. With our 510k studies nearing completion we will move to FDA consideration so that with the Agency’s clearance we are able to offer rapid susceptibility results to patients in the United States,” said Dr. Paul Rhodes, CEO of Specific.
Specific will be demonstrating the Reveal Rapid AST system at its exhibit at the 32nd European Congress of Clinical Microbiology & Infectious Diseases in Lisbon, Portugal April 23-26 and ASM Microbe June 9-13 in Washington, D.C.
Specific Diagnostics has developed in vitro diagnostic systems based upon a unique, patented metabolomic signature technology that enables rapid detection and identification of microorganisms as they grow in culture. Its first commercial application applies this fundamental new platform to the rapid determination of antimicrobial susceptibility directly from positive blood cultures, as well as isolate dilutions. The SPECIFIC REVEAL® Rapid AST System is not yet cleared by the FDA for use in diagnostic procedures in the United States. The SPECIFIC REVEALTM is CE Marked and available for use in Europe and in other jurisdictions outside the United States for which regulatory clearance is based upon the CE Mark. Specific is based in San Jose, CA, with subsidiaries in Ireland, France and the UK.
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