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Precision BioLogic Innovates Hemophilia Testing

Precision BioLogic Inc., a renowned developer in hemostasis diagnostics, has unveiled the upgraded capabilities of its CRYOcheck Chromogenic Factor VIII assay, aligning with the anticipated new treatments for hemophilia, such as Mim8—a next-generation bispecific antibody. This advancement is designed to assist clinical laboratories in providing precise monitoring during hemophilia A treatment.

The original CRYOcheck Chromogenic Factor VIII assay was developed in response to the increasing demand for robust chromogenic assays. Since its FDA approval in 2020, it has become a standard tool for clinical labs to identify Factor VIII deficiencies and manage hemophilia A effectively. Now, Precision BioLogic is reinforcing its market leadership by introducing innovative solutions that will facilitate accurate lab testing as new therapies become available.

Paul Empey, President and CEO of Precision BioLogic, stated, "We have taken a great assay and made it even better. Our goal is to ensure that labs are prepared to deliver accurate results when new treatments are available, making this process as straightforward as possible."

As new hemophilia medications enter the market, accurately determining drug concentrations in human plasma is essential for effective therapeutic management. While drugs like Mim8 are promising in enhancing the lives of individuals with hemophilia A, studies have revealed that many existing assays are sensitive to Mim8, rendering them less effective in monitoring native Factor VIII or conventional replacement activities in plasma when Mim8 is present.

The updated CRYOcheck Chromogenic Factor VIII assay not only meets current demands but anticipates future needs of hemophilia testing laboratories. Data submitted to the FDA as part of the recent 510(k) filing indicated that therapeutic concentrations of Emicizumab, a first-generation bispecific antibody, and anticipated therapeutic levels of Mim8 do not compromise the assay's performance. Moreover, Precision BioLogic has validated the assay's capability to assess the efficacy of leading Factor VIII replacement therapies accurately.

To ensure uninterrupted testing for laboratories, the assay will continue to be supported by all current automated coagulation analysis devices, with a quantification limit of 0.5% FVIII activity and a test range of 0-200% FVIII depending on the equipment used. The test is optimized to cater to laboratories of all sizes, enhancing efficiency, reducing rejection rates, and ensuring result accuracy. The components are frozen, allowing for rapid and straightforward preparation.

This innovative assay has obtained compliance for sale in the U.S., Canada, EU, UK, Australia, and New Zealand and will become commercially available later this year. Precision BioLogic is committed to assisting labs with a seamless transition to the new kit, offering immediate access or deferred adoption options.

The Hemophilia Portfolio of Precision BioLogic

Precision BioLogic, along with its subsidiary Affinity Biologicals, consistently develops clinical and scientific solutions for hemophilia and other bleeding disorders. Their spectrum of cryogenic diagnostic products encompasses a chromogenic Factor IX assay, numerous Factor-deficient plasmas, and a range of tested plasmas. Affinity Biologicals provides Factor inhibitor plasmas for research purposes and various Factor antigen kit mixes for numerous applications.

Understanding Hemophilia A

Hemophilia A is an inherited bleeding disorder characterized by a deficiency in coagulation Factor VIII in the blood. Individuals with this condition experience prolonged bleeding episodes, which can lead to severe joint damage and potentially life-threatening hemorrhages. The severity of the condition correlates with the degree of the factor deficiency; those with severe hemophilia may bleed into muscles and joints frequently, while moderate and mild cases might see less frequent episodes. Common scenarios triggering bleeding include surgical procedures or significant injuries, with the potential for spontaneous bleeding occurring in advanced cases.

Although there is no definitive cure for hemophilia A, a variety of effective treatments are available today, including standard concentrates and extended half-life clotting factor concentrates administered through intravenous infusions. More recent therapeutic replacements, such as Emicizumab and the anticipated Mim8, aim to restore hemostasis without requiring direct replacement of the missing clotting factor.

About Precision BioLogic

Precision BioLogic Inc. develops, manufactures, and markets the CRYOcheck™ line of frozen products utilized globally by clinicians to diagnose coagulation disorders. In November 2018, Precision BioLogic expanded its capabilities by acquiring Affinity Biologicals, augmenting its offerings with an extensive range of coagulation-related antibodies and further products and services. For more information, visit www.precisionbiologic.com.