The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Abionic SA's CAPSULE PSP, a novel in vitro diagnostic test designed for the early detection of sepsis. This clearance marks a significant advancement in sepsis diagnostics, potentially allowing for earlier intervention and improved patient outcomes. The test identifies Pancreatic Stone Protein (PSP), an emerging biomarker for sepsis, offering clinicians a tool for screening and early detection 24-48 hours sooner than current standard methods.
PSP, produced by the pancreas and immune cells, exhibits elevated levels in response to infections and inflammation. Clinical studies have demonstrated that PSP has significant sensitivity and specificity in detecting sepsis, especially in critically ill patients. Elevated PSP levels closely correlate with the progression of sepsis, enabling healthcare professionals to initiate sepsis bundles earlier and improve patient outcomes.
The FDA clearance underscores the accuracy and reliability of the CAPSULE PSP test, which is also supported by existing certifications from the EU CE, EU IVDR, and the Australian Therapeutic Goods Administration (TGA). This regulatory validation paves the way for the global implementation of the PSP test, highlighting its potential to transform sepsis diagnostics.
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 cooperation agreement with Abionic SA and LASCCO SA, initiated in October 2023. Leveraging this collaboration and the recent FDA approval, Fapon is actively engaged in the development and commercialization of PSP on its chemiluminescent immunoassay (CLIA) analyzer within China.
Fapon's broader research interests extend beyond sepsis, encompassing infectious diseases, neurodegenerative disorders, anti-aging, and AI-driven biomarkers. The company is committed to strengthening its R&D capabilities through global research centers, recruitment of industry experts, and strategic investments in breakthrough technologies.
Fapon aims to deliver innovative, high-quality IVD products and services, providing earlier, more accurate, convenient, and accessible diagnostic solutions to its partners. The company's integrated solutions span raw materials, reagents, and innovative open instrument platforms, establishing it as a leading supplier in in-vitro diagnostics with a presence in 68 countries and regions, serving over 2,500 business partners worldwide.
