Precision BioLogic Transforms Hemophilia Testing with Innovative Assay Updates

Innovation in Hemophilia Testing by Precision BioLogic

Precision BioLogic Inc., a pioneer in the field of hemostasis diagnostics, is making waves with the updated capabilities of its CRYOcheck Chromogenic Factor VIII assay. This development not only showcases Precision BioLogic's commitment to leading the charge in hemophilia testing but also positions the company favorably in anticipation of new, innovative treatments in hemophilia care.

Launched in 2020, the CRYOcheck assay was the first of its kind to receive FDA clearance for automated use in clinical laboratories. Its development was a direct response to the rising demand for advanced chromogenic assays by medical professionals. The assay serves a critical role in diagnosing factor VIII deficiency and in managing hemophilia A treatment protocols. Now, the company is set to enhance the assay’s utility with updates that cater to emerging therapies like Mim8—a promising next-generation bispecific antibody for hemophilia A treatment.

Paul Empey, the CEO and President of Precision BioLogic, emphasizes the importance of these enhancements. “We took a great assay and made it even better,” he remarks. The ambition is clear: to equip laboratories with the tools needed for accurate diagnostics as new treatment options come to market, ensuring labs can deliver timely and precise results necessary for patient care.

Challenging the Status Quo

As hemophilia treatments evolve, so too must the assays used to measure therapeutic levels in patient plasma. Notably, newer treatments, including Mim8, demonstrate significant potential in improving the quality of life for individuals affected by hemophilia A. However, existing assays may not accurately account for these advancements, which is where the updated CRYOcheck steps in.

Recent data submitted to the FDA highlights how the updated assay effectively measures therapeutic levels of both Emicizumab and Mim8 without interference. Such a feature is critical, as it allows for reliable monitoring of treatment without compromising the accuracy of FVIII level assessments in plasma. The updated CRYOcheck is designed to deliver results efficiently, with a limit of quantification reaching a remarkable 0.5% FVIII activity and an impressive test range of 0-200% FVIII. This broad range makes it suitable for laboratories of all sizes, enhancing workflow efficiency and minimizing wastage.

Ensuring Accessibility

Recognizing the importance of uninterrupted testing services, Precision BioLogic has ensured that the new assay remains compatible with all current automated coagulation analyzers. This continuity is crucial for laboratories transitioning to the enhanced kit, which is set to be commercially available soon across various regions, including the United States, European Union, Australia, and New Zealand.

Transitioning labs can do so immediately, or they may choose to adopt the new kit at a later time, allowing for flexibility based on their unique operational needs. To address potential challenges during this period of change, Precision BioLogic has resources in place for a seamless transition, ensuring that labs can continue providing essential services without interruption.

The Bigger Picture in Hemophilia Care

The updates to the CRYOcheck assay indicate Precision BioLogic's ongoing investment in clinical and research solutions for hemophilia and various bleeding disorders. Together with its subsidiary, Affinity Biologicals, the company is dedicated to developing cutting-edge diagnostics and treatment solutions. Their expansive range includes not only the CRYOcheck diagnostic products but also a variety of factor-deficient plasmas, providing vital resources for research and clinical applications.

Hemophilia A, characterized by a deficiency of clotting factor VIII, represents a significant healthcare challenge. Patients face prolonged bleeding episodes, which may lead to severe joint damage and life-threatening hemorrhages. While no cure exists, advancements in treatment options, including standard factor concentrates and innovative therapies like Mim8, provide hope for improved management of this condition. These developments mark significant milestones in improving the quality of life for individuals affected by this chronic disorder.

Conclusion

Precision BioLogic's latest advancements in the CRYOcheck Chromogenic Factor VIII assay illustrate a proactive approach in the shifting landscape of hemophilia treatment. With these improvements, medical professionals will be better equipped to provide accurate monitoring of therapies, ultimately enhancing patient care. As new therapies continue to emerge, Precision BioLogic's commitment to innovation ensures that they remain at the forefront of hemostasis diagnostics.