Precision BioLogic Inc., a leading developer of hemostasis diagnostic products, is pleased to announce FDA 510(k) clearance and the launch of its CRYOcheck™ Factor VIII Inhibitor Kit in the U.S. This clearance follows approvals received from regulatory authorities in Canada, the European Union, Australia, and New Zealand, where the kit launched in February of this year.
The presence of factor VIII (FVIII) inhibitors reduces therapy effectiveness and is one of the most complex and costly complications for people with hemophilia A. Because of this, it is important for clinical laboratories to have a testing system that can accurately and precisely quantify FVIII inhibitors in patient samples.
Precision BioLogic developed the CRYOcheck Factor VIII Inhibitor Kit to address this challenge. It contains standardized components and a validated procedure to prepare patient samples for performing a modified Nijmegen-Bethesda assay as per the U.S.-based Centers for Disease Control and Prevention (CDC) recommendation.1 A modified Nijmegen-Bethesda assay is used to determine FVIII inhibitor levels in people with hemophilia A.
According to Paul Empey, President & CEO of Precision BioLogic, FDA 510(k) clearance of the CRYOcheck Factor VIII Inhibitor Kit is an exciting milestone for the company but more importantly, a step forward for patient care. “Enhancing patient care is at the core of everything we do at Precision BioLogic,” he explains. “Our kit will standardize the preparation of patient samples for inhibitor titer measurement. This, in turn, will help labs deliver accurate results for the diagnosis and routine monitoring of FVIII inhibitors.”
To eliminate FVIII depleted plasma as a potential source of variant and standardize inhibitor titer measurement, the kit was developed with the following components:
- Imidazole Buffered Pooled Normal Plasma
- Imidazole Buffered Bovine Serum Albumin
- Negative FVIII Inhibitor Control
- Positive FVIII Inhibitor Control
Like all of Precision BioLogic’s CRYOcheck products, kit components are frozen, allowing for fast and easy preparation.
About Hemophilia A and Inhibitors
Hemophilia A is an inherited bleeding disorder caused by insufficient clotting factor VIII (FVIII) in the blood. People with hemophilia A experience prolonged bleeding, which can lead to permanent joint damage and life-threatening hemorrhages. The standard treatment for people with hemophilia A without inhibitors is intravenous (IV) FVIII replacement therapy with recombinant FVIII (rFVIII) or plasma-derived FVIII (pdFVIII) concentrates. Prophylaxis, the regular infusion of clotting factor concentrates, is used to prevent bleeds thereby minimizing joint damage.
Unfortunately, up to 30% of people with hemophilia A develop inhibitors, an immune response to treatment with clotting factor concentrates. Inhibitors make it more difficult to manage and treat hemophilia. In fact, according to the World Federation of Hemophilia, apart from access to care and treatment, inhibitors are the most serious challenge in hemophilia care today.2 While routine blood tests may suggest the presence of anti-FVIII antibodies, specialized testing is important to confirm not only the presence of inhibitors but also the quantitation to effectively adjust treatment. Current methods for inhibitor testing vary from lab to lab.
About Precision BioLogic
Precision BioLogic Inc. is a privately-held company that develops, manufactures and markets the CRYOcheck™ line of frozen products used by medical professionals and researchers around the globe to diagnose coagulation disorders. Precision BioLogic also has several active initiatives with pharmaceutical partners who seek to ensure that the diagnostic implications for their novel therapeutic agents have been well characterized. In November 2018, Precision BioLogic acquired Affinity Biologicals, enabling the company to expand its clinical and research offerings to include an extensive line of coagulation-related antibodies as well as other products and services. For more information, visit www.precisionbiologic.com.
1 Miller CH, Platt SJ, Rice AS, Kelly F, Soucie JM, the Hemophilia Inhibitor Research Study Investigators. Validation of Nijmegen-Bethesda assay modifications to allow inhibitor measurement during replacement therapy and facilitate inhibitor surveillance. J Thromb Haemost 2012; 10: 1055–1061.
2 World Federation of Hemophilia. Current issues in inhibitors. Available at https://www.wfh.org/en/Current-issues-in-inhibitors. Accessed on January 21, 2019.