Abionic, a diagnostics firm specializing in rapid early detection, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its IVD Capsule PSP test for sepsis.
The test has been certified under the European Union's In Vitro Diagnostic Regulation (IVDR) since July 2022; the FDA clearance will enable the Epalinges, Switzerland-based Abionic to expand into the U.S. market, the firm said in a statement.
The assay, which runs exclusively on Abionic's abioSCOPE nanofluidics-based rapid diagnostics platform, measures levels of pancreatic stone protein (PSP). Clinical studies have shown that elevated PSP levels correlate closely with sepsis progression, Abionic noted, adding that PSP can be used as a sepsis screening tool 24 to 48 hours earlier than current standard approaches.
"Achieving FDA 510(k) clearance for IVD Capsule PSP marks a significant milestone for Abionic and confirms our ability to meet the need for quick & reliable sepsis testing," said Patrick Pestalozzi, Abionic's CEO.
Sepsis, a life-threatening syndromic response to an existing infection, affects approximately 50 million patients annually, of whom 11 million die, accounting for about 20% of global deaths. Early detection of sepsis is critical as treatment for the infection is time-sensitive, and its nonspecific symptoms make it difficult to diagnose.
