Monitoring Dabigatran (Pradaxa)

Donna Lawler commented on Hyphen BioMed’s Hemoclot Thrombin Inhibitor assay for Dabigatran. I spoke with Ann Workman of Aniara Diagnostica, LLC at the Mayo Medical Labs Thrombophilia meeting yesterday, who said the assay along with its validators and controls, are currently under 510K review at the FDA. Aniara markets Hyphen’s materials in North America, and they are hoping for FDA clearance later this year. We won’t have US reimbursement for the assay until it is FDA-cleared.