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Precision BioLogic Expands CRYOcheck Chromogenic Factor VIII Assay

In an innovative move that is set to redefine hemophilia testing, Precision BioLogic Inc., a prominent leader in hemostasis diagnostic products, has announced the enhanced capabilities of its CRYOcheck Chromogenic Factor VIII assay. This development is particularly focused on preparing clinical laboratories for the anticipated introduction of new hemophilia treatments, including Mim8, a next-generation bispecific antibody targeting hemophilia A.

Launched in 2020, the CRYOcheck Chromogenic Factor VIII assay stands as a pioneering FDA-cleared chromogenic assay. It was uniquely designed for use on automated instruments, which has made it a favorite among clinical laboratories for identifying Factor VIII (FVIII) deficiency and managing hemophilia A effectively. According to Precision BioLogic's President and CEO Paul Empey, the aim of the enhancement is to equip laboratories with tools that allow them to deliver precise results as novel treatments become available. Empey stated, "We took a great assay and made it even better. 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."

With advancements in hemophilia therapies, laboratories must ensure that they can accurately report therapeutic drug levels in patients' plasma, which is crucial for effective treatment management. Unfortunately, many conventional assays can show sensitivity to new therapies such as Mim8, which presents challenges in monitoring native FVIII or traditional FVIII replacement activities. Hence, the upgraded CRYOcheck assay strategically addresses these challenges, providing a means to ensure efficacy in reporting under the influence of emerging therapies.

Data submitted to the FDA as part of the recent 510(k) application demonstrated that the assay performs reliably, even in the presence of therapeutic levels of Emicizumab and prospective levels of Mim8. Furthermore, the assay has proven effective in accurately assessing the potency of leading FVIII replacement products—a critical component for laboratories managing hemophilia patients.

The CRYOcheck assay continues to be highly compatible with existing automated coagulation analyzers, showcasing a limit of quantification for FVIII activity at 0.5% and a test range of 0–200% among different laboratory setups. This adaptability ensures that labs of all sizes can efficiently use the assay, reduce waste, and maintain accuracy in their testing results. To facilitate usage and trail ease, the components are sold frozen, allowing rapid preparation for testing.

Currently, the test has received clearance for commercial sale across multiple regions, including the United States, Canada, European Union, United Kingdom, Australia, and New Zealand, with plans for availability later this year. Precision BioLogic has put forth structured resources to help labs transition smoothly to the new kit, allowing immediate adoption or a more staggered approach if desired.

A Broader Vision for Hemophilia Treatment Solutions

Precision BioLogic, alongside its subsidiary Affinity Biologicals, is committed to advancing clinical and research solutions tailored for hemophilia and various other bleeding disorders. Their array of frozen CRYOcheck diagnostic products includes a range of assays and factor-deficient plasmas aimed at providing comprehensive options for laboratories. Affinity Biologicals contributes with factor inhibitor plasmas designated for research, highlighting the company's robust and diversified approach to tackling hemophilia-related challenges.

Understanding Hemophilia A

Hemophilia A is a hereditary disorder characterized by insufficient amounts of clotting factor VIII in the blood, leading to excessive bleeding and potential long-term complications such as joint damage and severe hemorrhages. The severity of this condition varies widely among individuals, leading to an increase in treatment needs. Despite the absence of a cure, numerous treatments now exist aimed at managing symptoms, including standard and extended half-life clotting factor concentrates provided intravenously, along with innovative therapies like Emicizumab and the promising Mim8, which seek to restore balance in hemostasis without necessitating the replacement of missing clotting factors.

About Precision BioLogic

Precision BioLogic Inc. specializes in the development, production, and marketing of the CRYOcheck™ series of frozen products employed by professionals worldwide to diagnose coagulation disorders. After acquiring Affinity Biologicals in November 2018, Precision BioLogic significantly broadened its clinical and research capabilities, inclusive of a rich portfolio of coagulation-related antibodies and additional relevant products and services. For more detailed information, visit www.precisionbiologic.com.

References

1. National Hemophilia Foundation. MASAC Document #228. MASAC Statement Regarding Use of Various Clotting Factor Assays to Monitor Factor Replacement Therapy.
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.