Precision BioLogic’s Factor IX Assay Cleared for Hemophilia B

Precision BioLogic’s CRYOcheck Chromogenic Factor IX assay has gained FDA clearance for identifying factor IX deficiency in plasma — an indicator of hemophilia B, a rare genetic bleeding disorder.

The assay, which changes color to indicate result levels, is the first available in the U.S. for factor IX, a protein needed for blood clotting to seal a wound and promote healing.

Nova Scotia-based Precision BioLogic launched the assay in Canada, the EU, UK, Australia, and New Zealand in 2022. The company previously released a chromogenic assay for factor VIII for diagnosis of hemophilia A in 2020.