FDA Clears CRYOcheck Lab Test of Factor VIII Activity in Hemophilia A
The U.S. Food and Drug Administration (FDA) has cleared for use CRYOcheck Chromogenic Factor VIII, Precision BioLogic‘s lab test to monitor factor VIII activity in the blood of hemophilia A patients ages 2 and older and help in disease management, the company said in a press release.
The clearance means the FDA agrees with the manufacturer that a medical device is similar to a previously approved product. In such a 510(k) premarket submission, companies need to present data supporting similarity with one or more marketed devices.
CRYOcheck’s availability in the U.S. follows previous authorizations from regulatory authorities in Canada, the European Union (EU), Australia, and New Zealand, where the assay launched earlier this year.
Gene mutations that cause hemophilia A prevent normal production of the FVIII clotting factor, putting patients at high risk for uncontrolled bleeding. To lower such risk, people with hemophilia A receive synthetic FVIII replacement therapy.
Detection methods currently vary from lab to lab, with no FDA-approved gold standard as a reference.
The National Hemophilia Foundation has called for manufacturers to make chromogenic assays and testing panels available for clinical labs in the U.S.
The CRYOcheck assay seeks to address this need. The method is validated for use on current automated coagulation analyzers and covers a wide analytic test range, being able to detect FVIII activity from 0–200% of normal levels. It also is formatted for use in laboratories of any size, with the goal of increasing efficiency, reducing waste, and ensuring accuracy of results.
According to Precision, CRYOcheck is the only commercially available, FDA-cleared chromogenic FVIII assay that can be used with automated instruments to detect FVIII activity, including in patients with severe FVIII deficiency (less than 1% activity).
Precision announced plans to host a free online webinar to discuss the benefits of chromogenic factor VIII testing with focus on the CRYOcheck assay. Those interested in participating can register here.
This is Precision’s second commercial hemophilia-related test kit. The first, CRYOcheck Factor VIII Inhibitor Kit, is designed to measure levels of inhibitors targeting FVIII replacement therapies, and has cleared by regulatory agencies in the U.S., Canada, and the EU.
“Last year we introduced a kit to help clinical laboratories accurately and precisely quantify FVIII inhibitors in patient samples,” said Paul Empey, Precision BioLogic’s CEO. “With the launch of our latest product, we have taken a leadership role in the coagulation diagnostics industry by bringing novel, authorized solutions to clinical labs conducting hemophilia testing.”
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