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Abionic's IVD CAPSULE PSP Receives FDA Clearance for Early Sepsis Detection

• Abionic's IVD CAPSULE PSP test has been granted FDA 510(k) clearance, marking a significant advancement in the rapid detection of sepsis in the U.S. • The IVD CAPSULE PSP measures Pancreatic Stone Protein (PSP) levels, enabling earlier sepsis detection than current methods by 24-48 hours. • The test runs on the abioSCOPE platform, providing lab-quality results from a single drop of blood within minutes, facilitating quicker clinical decisions. • This FDA clearance supports Abionic's expansion into the U.S. market, offering clinicians a tool to improve sepsis-related outcomes.

Abionic, a medical diagnostics company, has announced that its IVD CAPSULE PSP test has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the early detection of sepsis. This clearance will allow clinicians to accelerate the time-to-detection of sepsis, a critical factor in improving patient outcomes.
Sepsis is a major global health threat, affecting approximately 50 million patients worldwide and causing 11 million deaths annually, representing 20% of all global deaths. In the United States alone, sepsis impacts 1.7 million individuals and incurs $38 billion in annual costs. Early detection is crucial, as the Sepsis Alliance estimates that 80% of sepsis-related deaths could be prevented with timely intervention.

The Role of Pancreatic Stone Protein (PSP)

Pancreatic Stone Protein (PSP) is an emerging biomarker for sepsis, enabling detection 24-48 hours earlier than current standard methods. Produced by the pancreas and immune cells, PSP levels increase in response to infections and inflammation. Clinical studies have demonstrated that elevated PSP levels correlate with sepsis progression, allowing healthcare professionals to initiate treatment protocols earlier and improve patient survival rates.

IVD CAPSULE PSP and abioSCOPE Technology

The IVD CAPSULE PSP test is designed to run on the abioSCOPE platform, a rapid diagnostics system that uses nanofluidics to deliver lab-quality results from a small blood sample within minutes. This integration into clinical workflows provides fast, accurate, and user-friendly results in critical care settings. By measuring PSP levels, the test helps clinicians make informed decisions and initiate appropriate treatments sooner.

Company Statement

"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."
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Abionic's CAPSULE PSP, an innovative test for early sepsis detection, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
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Reference News

[1]
FDA Clears Abionic's IVD CAPSULE PSP for the Early Detection of Sepsis - BioSpace
biospace.com · Oct 2, 2024

Abionic's IVD CAPSULE PSP test, cleared by the FDA, accelerates sepsis detection using PSP biomarker, running on the abi...

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