Chromogenic Factor VIII Assay Cleared for Sale in Canada, EU, Australia, and New Zealand

January 20, 2020
Precision BioLogic Inc., a leading developer of hemostasis diagnostic products, is pleased to announce the availability of its new CRYOcheck Chromogenic Factor VIII assay in Canada, the European Union, Australia, and New Zealand following market authorization by Health Canada and respective in-country regulatory authorities.
 
CRYOcheck Chromogenic Factor VIII is intended for use by clinical labs for the determination of FVIII activity in human plasma and as an aid in the management of hemophilia A. Studies1 have shown the chromogenic method to be less prone to interference from lipids or traces of heparin than clot-based FVIII activity tests, offering unsurpassed assurance in results, especially in cases of severe hemophilia A.
 
CRYOcheck Chromogenic Factor VIII has been designed to meet the needs of today’s hemophilia testing laboratories: validated for use on current automated coagulation analyzers, with a test range from 0–200% FVIII using one standard curve, and formatted to meet the needs of any size laboratory, increasing efficiency while ensuring accuracy of results.
 
Like all of Precision BioLogic’s CRYOcheck products, components are frozen, allowing for fast and easy preparation.
 
CRYOcheck Chromogenic Factor VIII is Precision BioLogic’s second hemophilia-related product to launch in less than a year.
 
“Last February, we introduced a kit to help clinical laboratories accurately and precisely quantify FVIII inhibitors in patient samples,” explains Paul Empey, President & CEO of Precision BioLogic. “With the launch of our latest product, we have taken a leadership role in the coagulation diagnostics industry by bringing novel, authorized solutions to clinical labs conducting hemophilia testing in Canada and beyond.”
 
Precision BioLogic has submitted a premarket notification for the device to the U.S. FDA for clearance, and is actively pursuing other opportunities to innovate in the field of hemostasis and diagnostics.
 
About Hemophilia A
 
Hemophilia A is an inherited bleeding disorder caused by insufficient clotting factor VIII (FVIII) in the blood. People with hemophilia A experience prolonged bleeding, which can lead to permanent joint damage and life-threatening hemorrhages. The level of severity depends on the amount of clotting factor missing from a person’s blood. People with severe hemophilia usually bleed frequently into their muscles or joints. They may bleed one to two times per week—often for no obvious reason. People with moderate hemophilia bleed less frequently, about once a month. They may bleed for a long time after surgery, a bad injury, or dental work. People with mild hemophilia usually bleed as a result of surgery or major injury. They do not bleed often and, in fact, some may never have a bleeding problem.
 
The standard treatment for people with hemophilia A is intravenous (IV) FVIII replacement therapy with recombinant FVIII (rFVIII) or plasma-derived FVIII (pdFVIII) concentrates. Prophylaxis, the regular infusion of clotting factor concentrates, is used to prevent bleeds thereby minimizing joint damage.
 
About Precision BioLogic
 
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.
 
1 Mosher KA and Adcock DM. Chromogenic factor VIII activity assay. American Journal of Hematology. 2014; 89(7): 781-783.