The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Abionic SA's CAPSULE PSP, an in vitro diagnostic test designed for the early detection of sepsis. This approval marks a significant advancement in sepsis diagnosis, potentially allowing for earlier intervention and improved patient outcomes. Sepsis, a life-threatening condition caused by the body's overwhelming response to an infection, affects millions worldwide and is a leading cause of mortality in hospitals.
Pancreatic Stone Protein (PSP) as a Biomarker
The CAPSULE PSP test measures the levels of Pancreatic Stone Protein (PSP), an emerging biomarker for sepsis. PSP is produced by the pancreas and immune cells, and its levels increase in response to infections and inflammation. Clinical studies have demonstrated that PSP can detect sepsis 24 to 48 hours earlier than current standard methods. This early detection is crucial, as it allows healthcare professionals to initiate sepsis bundles—a set of interventions including antibiotics and fluid resuscitation—sooner, potentially improving patient survival rates.
"Elevated PSP levels correlate closely with the progression of sepsis," according to clinical studies, allowing for timely clinical decisions.
Accuracy and Reliability
The FDA clearance underscores the accuracy and reliability of the CAPSULE PSP test. The test has already received certifications from the EU CE, EU IVDR, and the Australian Therapeutic Goods Administration (TGA), paving the way for its global implementation. The test's ability to provide early and accurate sepsis detection could significantly impact clinical practice, particularly in critically ill patients.
Fapon's Role in China
Fapon, a global life sciences company, has secured exclusive rights to utilize the PSP biomarker for sepsis diagnosis in China through a strategic partnership with Abionic SA and LASCCO SA. This collaboration allows Fapon to develop and commercialize PSP-based diagnostics on its chemiluminescent immunoassay (CLIA) analyzer within China. Fapon's commitment extends beyond sepsis, with ongoing research in infectious diseases, neurodegenerative disorders, and AI-driven biomarkers.
Clinical Significance
Early detection of sepsis is critical due to its rapid progression and high mortality rate. The current standard methods often rely on clinical signs and symptoms, which can be non-specific and may delay diagnosis. The CAPSULE PSP test offers a more objective and timely assessment, enabling healthcare providers to make critical decisions earlier in the course of the disease. By facilitating earlier intervention, the CAPSULE PSP test has the potential to reduce the severity of sepsis and improve patient outcomes.
