Precision BioLogic, a Dartmouth medtech company that sells diagnostic testing supplies, has received United States Food and Drug Administration approval for its product for the bleeding disorder Hemophilia B.

The Hemophilia test, also recently approved by Health Canada, is being released in response to increasing market demand for chromogenic assays and is the only Hemophilia B test of its kind available in the country, Precision said in a statement. Chromogenic assays measure the clotting properties of blood using coloured substrates — the substance on which an enzyme, such as those that aid in blood clotting, acts.

"Recognizing the need for FDA-cleared chromogenic assays, Precision BioLogic developed CRYOcheck Chromogenic Factor IX to meet the needs of today's clinical laboratories,” said CEO Paul Empey in a statement.

“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."

Founded in 1992, Precision sells a raft of diagnostic kits in Canada, the United States and Europe under its CRYOcheck brand, which freezes biological samples to aid in storage and reduce “reconstitution errors” that can result from other methods of preservation. The company has 57 employees on LinkedIn.

Hemophilia B is an inherited disorder caused by insufficient clotting factor IX, an enzyme, in patients’ bloodstreams. It can cause permanent joint damage and deadly hemorrhages, with sufferers bleeding directly into their joints as often as several times a week, but is treatable with intravenous medication.