Revolutionizing Hemophilia Care: Precision BioLogic’s Breakthrough CRYOcheck™ Factor VIII Deficient Plasma Now FDA-Cleared for U.S. Market
Halifax, NS – September 18, 2023 – Precision BioLogic Inc., an avant-garde force in hemostasis diagnostics, is thrilled to announce the monumental achievement of FDA 510(k) clearance for the launch of CRYOcheck™ Factor VIII Deficient Plasma with VWF in the United States.
This remarkable addition to Precision BioLogic’s esteemed lineage of factor deficient plasmas is a game-changer for clinical laboratories, designed to pinpoint factor VIII (FVIII) deficiency within human plasma and significantly enhance the management of hemophilia A. Boasting normal von Willebrand factor (VWF) levels but with both FVIII antigen and activity levels below 1%, its significance in shaping FVIII deficient substrates was substantiated in a groundbreaking study unveiled at ISTH 2021.
CRYOcheck Factor VIII Deficient Plasma with VWF arrives in a user-friendly frozen format, eradicating reconstitution errors and streamlining preparation time. Crafted from platelet-poor human plasma meticulously immunodepleted and scrutinized to feature less than 1% FVIII activity by both functional and antigenic methods. Furthermore, von Willebrand factor is thoughtfully incorporated, and the buffered plasma is then cryogenically preserved. Each batch is accompanied by VWF activity and antigen levels, ensuring unwavering precision.
This revolutionary product made its impactful debut in 2021, initially captivating the Canadian, EU, UK, Australian, and New Zealand markets. It now stands as Precision BioLogic’s tenth exceptional factor deficient plasma offering.
Paul Empey, the President, and CEO of Precision BioLogic, underscores the company’s mission: “Precision BioLogic equips laboratory professionals with powerful tools to expedite and enhance decision-making. CRYOcheck Factor VIII Deficient Plasma with VWF offers laboratories a readily accessible and dependable alternative to congenital FVIII deficient plasmas, and its adoption has already made significant waves within the hemophilia research and pharmaceutical manufacturing communities.”
About Precision BioLogic
Unlocking Secrets of Blood: Precision BioLogic Inc., a dynamic innovator operating behind the scenes, spearheads the development, production, and worldwide distribution of the CRYOcheck™ range of frozen diagnostic products. These vital tools are wielded by the global medical community and researchers in their quest to decipher the mysteries of coagulation disorders.
But Precision BioLogic’s mission goes beyond diagnostics. They’re at the forefront of pioneering partnerships with pharmaceutical visionaries. These collaborations ensure that the diagnostic implications for cutting-edge therapeutic agents are meticulously explored and understood, opening doors to transformative treatments.
In a significant move in November 2018, Precision BioLogic welcomed Affinity Biologicals into its fold. This strategic acquisition expanded the company’s clinical and research horizons, enriching their offerings with a comprehensive catalog of coagulation-related antibodies and a diverse array of products and services. Now, they stand as a powerhouse, driving innovation and progress in the realm of healthcare and diagnostics.