#USA #Halifax #Mim8 #CRYOcheck #Hemophilia Testing

Precision BioLogic Leading the Charge in Hemophilia Testing

Precision BioLogic Inc., a prominent player in the field of hemostasis diagnostic products, has unveiled the expanded functionality of its CRYOcheck Chromogenic Factor VIII assay. This advancement is made in anticipation of emerging therapies such as Mim8, a next-generation bispecific antibody designed to treat Hemophilia A.

The CRYOcheck Factor VIII assay was originally developed in response to the growing demand for chromogenic assays and was launched in 2020. It stood out as the first commercially available Chromogenic Factor VIII assay approved by the FDA. Designed for use on automated instruments, it quickly gained popularity among clinical laboratories for identifying Factor VIII deficiency and managing Hemophilia A treatment. Now, Precision BioLogic is once again at the forefront, providing innovative solutions that clinical laboratories can deploy for hemophilia testing.

Paul Empey, the CEO of Precision BioLogic, stated, "We have enhanced an excellent assay to ensure that laboratories are prepared to provide accurate results as new treatments become available. We aim to make this transition as seamless as possible for the labs."

With new treatments emerging for hemophilia, it is vital that laboratories accurately report their concentration in human plasma as part of treatment management. Research indicates that many existing assays are sensitive to Mim8 and are therefore unsuitable for monitoring the activity of native FVIII or conventional FVIII replacement in its presence. The updated CRYOcheck Factor VIII assay meets the current needs of hemophilia laboratories while anticipating future requirements.

In the data presented to the FDA as part of its recent 510(k) submission, Precision BioLogic showed that therapeutic levels of Emicizumab, a first-generation bispecific antibody treatment, and expected therapeutic levels of Mim8 do not interfere with the performance of the assay. Furthermore, the company demonstrated the assay's capability to accurately assess the potency of leading FVIII replacement products.

To ensure that labs can continue testing seamlessly, the assay remains compatible with all current automated coagulation analyzers. It features a lower limit of quantitation of 0.5% FVIII activity and a testing range of 0 to 200% FVIII using a standard curve, depending on the instrument used. This design caters to laboratories of all sizes, enhancing efficiency, reducing waste, and ensuring precise results. The assay's components are kept frozen, allowing for quick and simple preparation.

The assay is authorized for sale in the United States, Canada, the European Union, the United Kingdom, Australia, and New Zealand, and will be commercially available by the end of the year. Precision BioLogic has resources available to assist laboratories in transitioning to the new kit, which can be adopted immediately or at a later date.

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 and other bleeding disorders. The frozen CRYOcheck diagnostic product line includes a Chromogenic Factor IX assay, several deficiency plasmas, and a variety of analyzed plasmas. Meanwhile, Affinity Biologicals provides factor inhibitor plasmas for research purposes and a kit mix of factor antigens for various applications.

Understanding Hemophilia A

Hemophilia A is an inherited bleeding disorder caused by insufficient levels of coagulation factor VIII in the blood. Individuals with this condition may experience prolonged bleeding, leading to permanent joint damage and potentially life-threatening hemorrhages. The severity of hemophilia A depends on the amount of coagulation factor that is deficient in a person's blood. Severe cases may bleed frequently into muscles or joints, often with no apparent cause, while moderate cases may bleed about once a month. Mild cases usually experience bleeding primarily during significant injuries or surgeries.

While there is currently no cure for hemophilia A, many treatments are available, including standard and extended half-life clotting factor concentrates administered via intravenous infusions. Newer treatments such as Emicizumab and the anticipated Mim8 therapy aim to rebalance hemostasis without needing factor replacement.

For more information regarding Precision BioLogic and their hemophilia portfolio, visit www.precisionbiologic.com.