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Precision BioLogic Nabs FDA 510(k) Clearance for Factor IX Deficiency

NEW YORK – Precision BioLogic said Thursday it secured US Food and Drug Administration 510(k) premarket clearance for its Cryocheck Chromogenic Factor IX test for managing hemophilia B.

The Nova Scotia-based firm said the test, which is for use by laboratories to identify factor IX activity and deficiency in human plasma, is the first chromogenic FIX assay cleared by the agency. The test is validated for use on automated coagulation analyzers with a test range of zero to 200 percent FIX activity using one standard curve, and its frozen format allows for fast and easy preparation, the company said.

"With the emergence of new therapies, including extended half-life FIX replacements and gene therapy, there has never been a stronger need for accurate, reliable hemophilia tests," Precision BioLogic CEO Paul Empey said in a statement.

The firm also launched sales of the test last year in Canada, Europe, the UK, Australia, and New Zealand. The firm began selling in 2020 its Chromogenic Factor VIII assay to aid in the diagnosis of hemophilia A in North America, Europe, the UK, and Australasia.