NEW YORK — Abionic said Wednesday that its IVD Capsule PSP test for the early detection of sepsis has received 510(k) clearance from the US Food and Drug Administration.
The point-of-care test is designed to measure levels of pancreatic stone protein (PSP) in capillary whole blood or venous whole blood. It runs on the company's AbioScope nanofluidics testing platform and provides results within five minutes.
PSP is produced by the pancreas and immune cells in response to infections and inflammation, and elevated levels of the protein are closely correlated with the progression of sepsis, according to the Swiss company.
Abionic received CE marking for the IVD Capsule PSP test in early 2017 and EU IVDR certification in mid-2022. The test is being developed for the Chinese market by Fapon under an exclusive license from Abionic and Lascco, which helped develop the test.