CRYOcheck™ Chromogenic Factor IX Assay Authorized for Sale in Canada, EU, UK, and Australasia
May 9, 2022
Precision BioLogic Inc., a leading developer of hemostasis diagnostic products, is pleased to announce the launch of its new CRYOcheck Chromogenic Factor IX assay in Canada, the European Union, United Kingdom, Australia, and New Zealand following market authorization by Health Canada and respective in-country regulatory authorities. The announcement was made at the World Federation of Hemophilia Congress taking place in Montreal, May 8–11, 2022.
With the emergence of extended half-life factor IX (FIX) replacement therapies, researchers and laboratorians have identified the growing importance of chromogenic assays along with one-stage clotting assays to effectively monitor factor replacement therapy.¹
In response to the demand for chromogenic assays, Precision BioLogic developed CRYOcheck Chromogenic Factor IX to meet the needs of today’s clinical laboratories. Intended for the determination of FIX activity in human plasma and as an aid in the management of hemophilia B, the assay is validated for use on current automated coagulation analyzers, with a test range from 0–200% FIX activity using one standard curve*, and formatted to meet the needs of any size laboratory, increasing efficiency, reducing wastage and ensuring accuracy of results.
CRYOcheck Chromogenic Factor IX is the only Health Canada authorized chromogenic FIX assay and one of only three such CE marked assays. Its unique frozen format allows for fast and easy preparation.
CRYOcheck Chromogenic Factor IX is Precision BioLogic’s second hemophilia-related chromogenic assay. In 2020, the company successfully launched its Chromogenic Factor VIII assay for the diagnosis of hemophilia A throughout North America, the EU, and Australasia.
“With the launch of CRYOcheck Chromogenic Factor IX, our latest in a series of novel, regulatory-compliant solutions, we build on our leadership role in the coagulation diagnostics industry and our commitment to improving hemophilia testing,” says Paul Empey, President & CEO of Precision BioLogic.
U.S. FDA clearance for Precision BioLogic’s CRYOcheck Chromogenic Factor IX assay is pending.
About Hemophilia B
Hemophilia B is an inherited bleeding disorder caused by insufficient clotting factor IX (FIX) in the blood. People with hemophilia B 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 B is intravenous (IV) FIX replacement therapy with recombinant FIX (rFIX) or plasma-derived FIX (pdFIX) 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.
* may vary based on the instrumentation in use.
¹ Gray E, Kitchen S, Bowyer A, et al. Laboratory measurement of factor replacement therapies in the treatment of congenital haemophilia: A United Kingdom Haemophilia Centre Doctors’ Organisation guideline. Haemophilia. 2020;26:6–16. https://doi.org/10.1111/hae.13907