The newly cleared test detects sepsis earlier than current standards by measuring levels of the pancreatic stone protein biomarker.
RT’s Three Key Takeaways:
- FDA 510(k) Clearance: The IVD Capsule PSP test has received FDA clearance to aid in early sepsis detection.
- Faster Sepsis Detection: The test identifies sepsis 24-48 hours earlier than current standards by measuring pancreatic stone protein (PSP) levels, a biomarker linked to sepsis progression.
- Improved Clinical Decision-Making: By providing rapid results through the abioSCOPE diagnostics platform, the test helps clinicians initiate earlier interventions for critically ill patients at risk of sepsis.
Abionic, an emerging medical diagnostics company focused on rapid early detection technologies, announced that its IVD Capsule PSP test has received 510(k) clearance from the US Food and Drug Administration (FDA) to accelerate the time-to-detection of sepsis.
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 PSP 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.
Results from Blood Drop
The IVD Capsure 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. 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, potentially improving outcomes.
“Achieving FDA 510(k) clearance for IVD Capsulre PSP marks a significant milestone for Abionic and confirms our ability to meet the need for quick and reliable sepsis testing,” says Patrick Pestalozzi, CEO at Abionic, in a release. “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.”
The test is already certified under the EU IVDR as of July 2022.
Photo caption: The IVD Capsure PSP runs on the abioSCOPE diagnostics platform.
Photo credit: Abionic
