Abionic’s IVD CAPSULE PSP for Early Sepsis Detection Wins FDA Nod

Abionic, a company focused on rapid early detection technologies, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its IVD CAPSULE PSP test to accelerate the time-to-detection of sepsis.
 
Pancreatic stone protein (PSP) is an emerging sepsis biomarker used as a screening tool for detection of sepsis 24-48 hours earlier than current standards. PSP levels increase in response to infections and inflammation. The company said clinical studies have demonstrated that elevated PSP levels correlate closely with sepsis progression.
 
The IVD CAPSULE PSP runs exclusively on abioSCOPE, a rapid diagnostics platform that uses nanofluidics to produce lab-quality results from a drop of blood in minutes, Abionic said. The company hopes the test can help clinicians make informed decisions and begin appropriate treatments earlier.

The technology is already certified under the EU’s IVDR as of July 2022.
 
“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, CEO at Abionic. “This clearance will allow us to deploy our solutions across the United States and provide clinicians in acute care settings with a proven solution to accelerate the Time-To-Detection of sepsis.”
 
Abionic began in 2010 with a vision that nanofluidics could transform diagnostics. The company has won multiple industry awards, including “Swiss MedTech of the year” in 2023.