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09.01.2020 Abionic integrates first patients in US clinical trial for sepsis diagnosis method
Biopôle, Lausanne, Switzerland, 9th January 2020 – Abionic SA, Swiss Medtech firm based in Lausanne, is initiating a pivotal clinical trial in the US for an innovative point-of-care diagnostic method for sepsis to validate the results of a first trial that took place in Europe in 2019, proving the suitability of Abionic’s sepsis test on the abioSCOPE® device to identify sepsis. The PSP test on the abioSCOPE® can diagnose sepsis 24 hours earlier than today’s standard of care for sepsis diagnosis. For the US version of the study, the first patients are now being integrated.
The study will be held in seven leading hospitals: Rhode Island Hospital in Providence, RI, Baystate Medical Center in Springfield, MA, Rush Medical University in Chicago, IL, and the Mercy Health clinics Saint-Vincent, Saint-Anne, and Saint-Charles, all located in Toledo, OH. The trial will support an FDA 510(k) filing. The goal of the study is to assess the performance of immunoassay measurements of pancreatic stone protein (PSP) performed on Abionic’s abioSCOPE® device. As indicated by earlier studies, PSP is the best marker to distinguish sepsis from non-infectious inflammation. The US study therefore seeks to confirm the results of the previously conducted European trials that found the PSP test on the abioSCOPE® is able to recognize sepsis earlier than other markers.