2024-10-31
Sat Nov 23
Abionic's CAPSULE PSP Receives FDA Approval for Early Detection of Sepsis; Fapon Introduces Exclusive PSP Solution in China via Licensing Collaboration
DONGGUAN,China,Oct. 31,2024 --Fapon,a global leading life sciences company,is thrilled to announce its PSP CLIA reagent solution which demonstrates promising outcomes in extensive clinical validation studies targeting Chinese population.
Leveraging its strategic partnership with Abionic SA and LASCCO SA,Fapon has gained exclusive rights to utilize the PSP biomarker for sepsis diagnosis in China. Recently,Abionicannounced that its innovative sepsis early detection test,IVD CAPSULE PSP,has received 510(k) clearance from the US Food and Drug Administration (FDA). This approval marks a significant advancement in the diagnosis and treatment 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 - 48h earlier than current standards to support critical time-sensitive decisions. Produced by the pancreas and immune cells,PSPlevels increase in response to infections and inflammation and has demonstrated significant sensitivity and specificity in detecting sepsis,particularly in critically ill patients. Clinical studies have shown that elevatedPSPlevels correlate closely with the progression of sepsis,allowing healthcare professionals to activate sepsis bundles earlier and improve outcomes.
The FDA clearance highlights the marker and test's accuracy and reliability,supported by existing certifications fromthe EU CE,EU IVDR,and the Australian Therapeutic Goods Administration (TGA). This sets the stage for PSP test's global implementation,emphasizing its potential impact on sepsis diagnostics.
In October 2023,Fapon entered into a strategic cooperation agreement with Abionic SA and LASCCO SA. This alliance grants Faponexclusive rights to utilize the PSP biomarker for sepsis diagnosis in China. Leveraging this collaboration and the test's recent FDA approval,Fapon is in the development and commercialization of PSP on its chemiluminescent immunoassay (CLIA) analyzer within the territory.
Beyond its focus in sepsis,Fapon is dedicated to advancing research in a range of critical areas,including infectious diseases,neurodegenerative disorders,anti-aging,AI-driven biomarkers and others. We continually strengthen our R&D capabilities through the establishment of global research centers,recruitment of industry-leading experts,and strategic licensing collaborations and investments in breakthrough technologies.
Moving forward,Fapon is committed to providing more innovative,high-quality IVD products and services,and bringing earlier,more accurate,more convenient,and more accessible diagnostic solutions to our partners.
About Fapon
Fapon is a global leading life sciences company dedicated to providing integrated solutions and services for diagnostics,biopharma and biotherapy. Integrating a one-stop solution on raw materials,reagents and innovative open instrument platforms,the Company has grown into a leading supplier in in-vitro diagnostics. Fapon boasts advanced innovations in therapeutics technologies and AI algorithm platforms with data insights that contribute to a better and healthier world. Supported by its strong global R&D,manufacturing,sales and service network,Fapon's products have established presence in 68 countries and regions,serving more than 2,500 business partners worldwide.
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