#USA #Halifax #Hemophilia #Precision BioLogic #CRYOcheck VIII

Precision BioLogic: Leading the Charge in Hemophilia Diagnostics

Precision BioLogic Inc. has announced an exciting advancement in the realm of hemophilia diagnostics with their enhanced CRYOcheck chromogenic factor VIII reagent. This innovative product is set to play a pivotal role in laboratories' readiness for emerging therapies such as Mim8, a next-generation bispecific antibody designed for hemophilia A treatment.

Background of CRYOcheck

The CRYOcheck chromogenic factor VIII reagent was born out of necessity to address increasing demands for chromogenic testing. Launched in 2020, this reagent became the first commercially available factor VIII chromogenic product approved by the FDA, optimized for automated instrumentation. This product has received acclaim from clinical labs for its effectiveness in detecting factor VIII deficiencies, thereby facilitating better management of hemophilia A.

Its recent advancements reaffirm Precision BioLogic's commitment to delivering innovative solutions in hemophilia testing. As Paul Empey, CEO of Precision BioLogic, states, "We have significantly improved an already excellent test. Our aim is to ensure that labs are equipped to produce accurate results as new treatments become available, and we want to streamline this process as much as possible."

Necessity for Enhanced Testing

With the development of novel hemophilia medications, precision in plasma drug levels measurement has become essential for effective treatment management. Advanced therapies, including Mim8, show promise in enhancing the quality of life for individuals with hemophilia A. However, existing assays may falter in accurately measuring native FVIII or standard FVIII replacement activities in the presence of Mim8.

The upgraded CRYOcheck reagent addresses these contemporary needs, ensuring that labs can reliably report plasma concentrations of these innovative treatments. According to the data submitted to the FDA with their recent 510(k) application, Precision BioLogic demonstrated that therapeutic levels of Emicizumab, a first-generation bispecific antibody treatment, and the anticipated therapeutic levels of Mim8 do not interfere with CRYOcheck's performance. The reagent has also shown a remarkable capability to accurately assess the potency of major FVIII replacement therapies.

Technical Specifications

The CRYOcheck reagent continues to be compatible with all current automated coagulation analyzers, maintaining a limit of quantification of 0.5% FVIII activity. Its testing range spans from 0 to 200% of FVIII activity, utilizing a standard curve based on the analytical instrument employed. Designed for labs of varying capacities, this reagent enhances efficiency, reduces waste, and ensures result precision. Furthermore, the reagent components are frozen, facilitating quick and effortless preparation.

Currently, the CRYOcheck reagent has received approval for sale in the United States, Canada, the European Union, the United Kingdom, Australia, and New Zealand, with marketing efforts set to expand later this year. Precision BioLogic has also established resources to assist laboratories in adopting this new kit smoothly, allowing for immediate or delayed transitions, based on their preference.

Comprehensive Hemophilia Portfolio

Precision BioLogic, alongside its subsidiary Affinity Biologicals, is dedicated to providing comprehensive clinical and research solutions for hemophilia and other coagulation disorders. Their extensive CRYOcheck product range features not only chromogenic factor IX reagents and various deficient factor plasmas but also a suite of dosing plasmas provided by Affinity Biologicals for research purposes and factor antigen kits tailored for diverse applications.

Understanding Hemophilia A

Hemophilia A is an inherited bleeding disorder caused by insufficient levels of factor VIII. Individuals affected can experience prolonged bleeding, leading to joint damage and, potentially, life-threatening hemorrhages. The severity varies based on how much factor VIII is present in a patient's bloodstream. Those with severe hemophilia A may experience bleeding episodes frequently, while those with moderate or mild forms bleed less often and generally only after significant injuries or surgeries.

While there is currently no cure, various treatments exist, including standard and extended half-life coagulation factor concentrates administered intravenously. New therapies like Emicizumab and Mim8 aim to rebalance hemostasis without requiring direct factor replacement.

About Precision BioLogic

Precision BioLogic Inc. designs, manufactures, and markets the CRYOcheck™ product line, utilized globally for diagnosing coagulation disorders. Their acquisition of Affinity Biologicals in November 2018 has expanded their offerings to include a broad range of coagulation-related antibodies and additional products. For further information, visit www.precisionbiologic.com.