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Precision BioLogic Announces FDA Clearance of Inhibitor Screening Kit

March 26, 2019
Precision BioLogic Announces FDA Clearance of Inhibitor Screening Kit

Precision BioLogic Inc has announced the U.S. Food and Drug Administration clearance and subsequent launch of its new factor VIII (FVIII) inhibitors screening product. According to a recent press release, the CRYOcheck™ Factor VIII Inhibitor Kit contains “standardized components and a validated procedure” to prepare patient samples for performing a modified version of the Nijmegen-Bethesda assay (MNBA). MNBA is a standard method for measuring inhibitors in hemophilia A patients.

The kit includes frozen plasma samples that closely resemble samples from individuals with hemophilia A with a history of FVIII inhibitors and also those from unaffected donors. The kit was developed in large part via a study that compared FVIII inhibitor values determined using the new MNBA kit with both a chromogenic assay (lab test that relies on color to signify a reaction) and a one-stage, clot-based FVIII assay. 

“Enhancing patient care is at the core of everything we do at Precision BioLogic,” said Paul Empey, President & CEO of Precision BioLogic. “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.”

Source: PRNewswire, March 13, 2019