Abionic’s IVD CAPSULE PSP Cleared by FDA

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Abionic’s IVD CAPSULE PSP test. The diagnostic for early sepsis detection has been certified under the EU IVDR since July 2022.
 
Sepsis is a global health threat affecting 50 million patients worldwide and leads to 11 million deaths, or 20% of all global fatalities. In the United States, it strikes 1.7 million patients and costs $38 billion annually, making it a major public health challenge. Sepsis is a time-sensitive emergency and according to the Sepsis Alliance, 80% of sepsis-related deaths could be prevented, but it remains notoriously difficult to diagnose due to the non-specific nature of its symptoms, which often resemble those of other common conditions. The timely and early detection of sepsis is critical to initiate optimal treatment protocols and increase the odds of patient survival.
 
Pancreatic Stone Protein (PSP) is an emerging sepsis biomarker used by clinicians as a screening tool for the early detection of sepsis 24 to 48 hours earlier than current standards to support critical time-sensitive decisions. Produced by the pancreas and immune cells, PSP levels increase in response to infections and inflammation and has demonstrated significant sensitivity and specificity in detecting sepsis, particularly in critically ill patients. Clinical studies have shown that elevated PSP levels correlate closely with the progression of sepsis, allowing healthcare professionals to activate sepsis bundles earlier and improve outcomes.
 
The IVD CAPSULE PSP runs exclusively on the abioSCOPE, a rapid diagnostics platform that leverages nanofluidics to deliver lab-quality results from a drop of blood within minutes. Seamlessly integrated into routine clinical workflows, the test delivers fast, accurate, and user-friendly results in critical care settings. By measuring PSP levels, which are directly linked to a patient’s risk of sepsis, the test enables clinicians to make informed decisions and initiate appropriate treatments earlier, improving outcomes.
 
“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 and reliable sepsis testing,” Abionic CEO Patrick Pestalozzi said. “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.”
 
Engineering ground-breaking medical technologies has been in the DNA of Abionic since its inception in 2010 on a vision nanofluidics could transform diagnostics. The winner of multiple industry awards, including “Swiss MedTech of the year” in 2023, Abionic is committed to providing healthcare professionals solutions with proven clinical utility. The abioSCOPE, a near-patient rapid diagnostic platform, integrates seamlessly into clinical workflows and delivers lab-quality results from a drop of blood within minutes, providing valuable clinical insights and actionable information at the point-of-care.