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Specific Diagnostics Announces the Results of Two Studies at Hospitals Within AP-HP (Assistance Publique-Hopitaux de Paris) Evaluating Performance of the Reveal Rapid AST System
Specific Diagnostics today announced results from two studies conducted in the Paris Teaching Hospital System (Assistance Publique-Hôpitaux Paris, AP-HP), Europe’s largest hospital network, reporting performance of the Reveal rapid antibiotic susceptibility testing (AST) system. Both studies, which comprised approximately 225 samples in total, found the same levels of accuracy (≈97% concordance versus the standard of care), with rapidity (≈5 hours) enabling same-shift action for escalation and deescalation of antibiotics.
While rapid ID instrumentation for blood stream infections is now widely available, clinicians often wait additional 1 to 2 days to receive the AST results required to identify the optimal antibiotic therapy, which the ID result alone does not enable. This delay results in overuse of costly broad spectrum, empiric antibiotic therapy, and can put patient lives at risk. Same-shift AST enables either timely deescalation to a focused and lower-cost therapy, eliminating harmful disruption of the microbiome, or immediate escalation to a drug of last resort in the increasingly prevalent case where multi drug resistant (MDR) infection is present, saving a life.
The first study, led by Dr. Martin Rottman, Professor of Clinical Microbiology at Université de VersaillesSt Quentin and Director of the Innovative Biomarkers Platform at Assistance Publique - Hôpitaux de Paris, France, was carried out at Hôpital Raymond Poincaré. “We are a leading center for the care of sepsis patients, and we believe that same-day susceptibility results are critical to the care of patients with blood stream infections,” said Pr. Rottman. “The Reveal performs as accurately as the current 2- day standard of care, yet can provide more complete results within our first shift. The instrument is going to open a new era in anti-infective Personalized Medicine.”
Dr. Laurent Dortet, Director of the Associate French National Reference Center for Antibiotic Resistance, at Hôpital Le Kremlin Bicêtre in Paris, who conducted the second study, noted: “We were pleased to see the Reveal system’s capability to detect and characterize resistance to antimicrobial agents which arises in the French hospital system. Reveal’s capability to phenotypically detect carbapenem resistance, regardless of the particular mechanism at play, will be of great relevance in addressing CRE (Carbapenem-resistance Enterobacteriaceae), surveillance of which is a central responsibility of our Centre.”
“We are very gratified to have engagement with leading microbiology researchers such as these and others in Paris and across France, our first market in Europe,” said Dr. Paul A. Rhodes, CEO of Specific. “To now announce and submit for publication a joint study with these distinguished labs will build awareness of the Reveal rapid AST system. We are honored to be doing this work with partners who are widely acknowledged leaders in the assessment of diagnostic methods to address the looming challenge of drug resistant infection.”
About Specific
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. Specific is based in Mountain View, CA, with subsidiaries in Ireland, France and the UK.