Dongguan, China – Fapon, a global life sciences company, is set to introduce its PSP CLIA reagent solution in China following the FDA approval of Abionic's CAPSULE PSP for early sepsis detection. This move is enabled by Fapon's strategic partnership with Abionic SA and LASCCO SA, granting them exclusive rights to utilize the PSP biomarker for sepsis diagnosis in China.
The FDA has granted 510(k) clearance to Abionic's IVD CAPSULE PSP, an innovative test designed for the early detection of sepsis. This approval signifies a major step forward in improving sepsis diagnosis and treatment outcomes.
PSP: An Emerging Biomarker for Early Sepsis Detection
Pancreatic Stone Protein (PSP) is emerging as a crucial biomarker for the early detection of sepsis, allowing clinicians to identify the condition 24 to 48 hours earlier 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, particularly in critically ill patients. Elevated PSP levels 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 PSP marker and test, which are also supported by 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 Strategic Collaboration and Commercialization Plans
In October 2023, Fapon entered into a strategic cooperation agreement with Abionic SA and LASCCO SA, securing exclusive rights to utilize the PSP biomarker for sepsis diagnosis in China. Building on this collaboration and the recent FDA approval, Fapon is actively developing and commercializing the PSP test on its chemiluminescent immunoassay (CLIA) analyzer within China.
Fapon is committed to advancing research in critical areas beyond sepsis, including infectious diseases, neurodegenerative disorders, anti-aging, and AI-driven biomarkers. The company is strengthening its R&D capabilities through global research centers, recruitment of industry experts, and strategic licensing collaborations and investments in breakthrough technologies.
Fapon aims to provide innovative, high-quality IVD products and services, delivering earlier, more accurate, convenient, and accessible diagnostic solutions to its partners.
