Proven CRYOcheck Chromogenic Factor VIII assay now offers expanded utility in anticipation of emerging treatments
HALIFAX, NS, Sept. 10, 2025 /PRNewswire/ -- Precision BioLogic Inc., a leading developer of hemostasis diagnostic products, is pleased to announce the expanded utility of its CRYOcheck Chromogenic Factor VIII assay in anticipation of emerging hemophilia treatments such as Mim8, a next generation bispecific antibody for the treatment of hemophilia A.
Precision BioLogic originally developed CRYOcheck Chromogenic Factor VIII in response to a growing demand for chromogenic assays1. Launched in 2020, it was the first commercially available, FDA-cleared chromogenic factor VIII (FVIII) assay designed for use on automated instruments and was readily welcomed by clinical labs to help identify FVIII deficiency and aid in the management of hemophilia A. And now Precision BioLogic is again leading the way in bringing novel, cleared solutions to clinical labs conducting hemophilia testing.
"We took a great assay and made it even better," explains Paul Empey, President & CEO of Precision BioLogic. "We want to ensure labs are ready and able to deliver accurate results when new treatments become available. And we want to make doing that as easy as possible for labs."
As new hemophilia drugs become available, it is crucial that labs can accurately report the level of those drugs in human plasma as part of managing treatment. While next generation bispecific antibody treatments such as Mim8 show great promise in enhancing quality of life for people with hemophilia A, studies2 show that many existing assays are sensitive to Mim8 and therefore not suitable for monitoring native FVIII or conventional FVIII replacement activities in plasma in the presence of Mim8.
The updated CRYOcheck Chromogenic Factor VIII meets the current needs of hemophilia testing labs while anticipating future requirements. In data submitted to the FDA as part of its recent 510(k) submission, Precision BioLogic proved that therapeutic levels of Emicizumab, a first-generation bispecific antibody treatment, and expected therapeutic levels of Mim8 do not interfere with the assay's performance. Furthermore, Precision BioLogic demonstrated the assay's ability to accurately evaluate the potency of leading FVIII replacement products.
To ensure continuity of testing for labs, the assay continues to be supported on all current automated coagulation analyzers, with a limit of quantification of 0.5% FVIII activity and a test range of 0-200% FVIII using one standard curve (depending on the instrument in use). It is formatted to meet the needs of any size laboratory, increasing efficiency, reducing wastage, and ensuring accuracy of results. Assay components are frozen, allowing for fast and easy preparation.
The test is cleared for sale in the United States, Canada, European Union, United Kingdom, Australia, and New Zealand, and will be commercially available later this year. Precision BioLogic has resources in place to help labs transition to the new kit smoothly and easily. Labs will be able to switch to the new kit immediately or may choose to transition later.
Precision BioLogic's Hemophilia Portfolio
Precision BioLogic and its subsidiary Affinity Biologicals have established-and continue to invest in-clinical and research solutions for hemophilia along with other bleeding disorders.
Precision BioLogic's line of frozen CRYOcheck diagnostic products also includes a chromogenic factor IX assay, numerous factor deficient plasmas, and a family of assayed plasmas while Affinity Biologicals offers factor inhibitor plasmas for research use and a mix of factor antigen kits for a variety of uses.
Learn more about Precision BioLogic's hemophilia portfolio.
About Hemophilia A
Hemophilia A is an inherited bleeding disorder caused by insufficient clotting factor VIII 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.
While there is no cure, there are many kinds of treatment available today including standard and extended half-life clotting factor concentrates given as intravenous infusions as well as newer non-factor replacement therapies, such as Emicizumab and the anticipated Mim8, that aim to rebalance hemostasis without the need for replacing the missing clotting factor.
About Precision BioLogic
Precision BioLogic Inc. develops, manufactures, and markets the CRYOcheck line of frozen products used by medical professionals around the globe to diagnose coagulation disorders. 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 National Hemophilia Foundation. MASAC Document #228. MASAC Statement Regarding Use of Various Clotting Factor Assays to Monitor Factor Replacement Therapy. Available at https://www.bleeding.org/sites/default/files/document/files/masac-228.pdf. Accessed on September 8, 2025. | |
2 The effect of a next generation factor VIII mimetic bispecific antibody (Mim8) on assays of factor VIII activity and thrombin generation. Bowyer, Annette Elizabeth et al. Journal of Thrombosis and Haemostasis, Volume 21, Issue 3, 480-487. |
For more information, contact: Elaine Benoit, Marketing & Communications Manager, Precision BioLogic, ebenoit@precisionbiologic.com / 902.430.7795
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