Blood Test for Factor IX Now Available in Canada, Other Countries

A blood test to determine the amount of active factor IX — the clotting factor that is missing in hemophilia B — in patients ages 2 and older is now available in clinical labs in Canada, the European Union, Australia, and New Zealand.

The test, called CRYOcheck Chromogenic Factor IX, was granted a license to enter the market by the respective in-country regulatory authorities. It is not yet for sale in the U.S., where its developer, Precision BioLogic, awaits approval by the U.S. Food and Drug Administration (FDA).

“With the launch of CRYOcheck Chromogenic Factor IX, our latest in a series of novel, regulatory-compliant solutions, we build on our leadership role in the coagulation diagnostics industry and our commitment to improving hemophilia testing,” Paul Empey, president and CEO of Precision BioLogic, said in a press release.

Hemophilia occurs when the body does not make enough clotting factors that help blood to clot. The type of hemophilia depends on the specific clotting factor that is missing. In the case of hemophilia B, it is factor IX.

As a way to prevent bleeding, patients receive replacement therapy with the clotting factor they are missing. To see how well replacement therapy is working, doctors may order a blood test to measure the activity of the replaced clotting factor.

Precision BioLogic developed a chromogenic test that measures the activity of factor IX in samples of human plasma — the clear fluid part of blood. The amount of active factor IX is calculated based on an automated measurement of color using a machine called a spectrophotometer.

It is able to measure the activity of factor IX in the range of 0–200%, meaning it can also be helpful for patients with severe hemophilia B, who have less than 1% of active IX in the blood.

The test is stored frozen, which allows for fast and easy preparation. It also is formatted for use in clinical labs of any size, with the goal of increasing efficiency, reducing waste, and ensuring accuracy of the results.

CRYOcheck Chromogenic Factor IX is the only chromogenic test for factor IX approved by Health Canada and one of only three such tests with CE marking. Its launch was announced at the 2022 World Federation of Hemophilia Congress, which was held May 8–11 in Montreal.

It is the company’s second chromogenic test to measure the activity of a clotting factor in patients with hemophilia. The first one was the CRYOcheck Chromogenic Factor VIII, which measures the activity of factor VIII — the clotting factor that is missing in patients with hemophilia A. It is available in the U.S., where it was cleared by the FDA in 2020, as well as in Canada, the European Union, Australia, and New Zealand.