Cision PR Newswire
Precision BioLogic's Factor VIII Deficient Plasma with VWF Now FDA-Cleared for Sale in U.S.
News provided byPrecision BioLogic
Sep 18, 2023, 10:00 AM ET
HALIFAX, NS, Sept. 18, 2023 /PRNewswire/ - Precision BioLogic Inc., a leading developer of hemostasis diagnostic products, is pleased to announce FDA 510(k) clearance and the launch of our new CRYOcheck™ Factor VIII Deficient Plasma with VWF in the U.S.
The latest in Precision BioLogic's family of factor deficient plasmas, CRYOcheck Factor VIII Deficient Plasma with VWF is intended for use in clinical laboratories to identify factor VIII (FVIII) deficiency in human plasma and aid in the management of hemophilia A. It has normal levels of von Willebrand factor (VWF) but both FVIII antigen and activity levels of less than 1%. The importance of FVIII antigen levels in the performance of FVIII deficient substrates was demonstrated in a study presented at ISTH 20211.
CRYOcheck Factor VIII Deficient Plasma with VWF comes in a convenient frozen format, which eliminates reconstitution errors and reduces preparation time. It is manufactured from platelet-poor human plasma, which is immunodepleted and assayed at less than 1% FVIII activity by functional and antigenic methods. Von Willebrand factor is added, and the buffered plasma is frozen. VWF activity and antigen levels are available for every lot.
CRYOcheck Factor VIII Deficient Plasma with VWF launched in Canada, the EU, UK, Australia and New Zealand in 2021. It is Precision BioLogic's tenth factor deficient plasma offering.
"Precision BioLogic provides tools to help laboratory professionals make the best decisions, faster," says Paul Empey, the company's President and CEO. "CRYOcheck Factor VIII Deficient Plasma with VWF offers labs a readily available and reliable alternative to congenital FVIII deficient plasmas. In fact, the product has already gained significant traction within the hemophilia research and pharmaceutical manufacturing community."
Precision BioLogic Inc. is a privately held company that develops, manufactures and markets the CRYOcheck™ line of frozen products used by medical professionals and researchers around the globe to diagnose coagulation disorders. Precision BioLogic also has several active initiatives with pharmaceutical partners who seek to ensure that the diagnostic implications for their novel therapeutic agents have been well characterized. In November 2018, Precision BioLogic acquired Affinity Biologicals, enabling the company to expand its clinical and research offerings to include an extensive line of coagulation-related antibodies as well as other products and services. For more information, visit www.precisionbiologic.com.
A. Wood, N. Kesavan, A. Sadeghi-Khomami, K. Black, M. Boylan, R. Ni, J. Della Maestra, P. Erb, D. Foulon, H. Hoogendoorn; ISTH 2021; The Impact of Inactive FVIII Antigen in Factor VIII Deficient Plasma on the Measurement of FVIII Inhibitors.
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SOURCE Precision BioLogic
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