Hemophilia lab test update ensures accuracy with new treatments
Precision Biologic says it will be commercially available this year
Precision Biologic has announced an update of its Cryocheck Chromogenic Factor VIII assay, a test used to help diagnose and manage hemophilia A.
The update, which is expected to be commercially available in the coming months, will ensure that the assay’s accuracy is not compromised by a new up-and-coming class of hemophilia treatments, according to Precision.
“We took a great assay and made it even better,” Paul Empey, president and CEO of Precision, said in a company press release.
Updated hemophilia test will work with antibody-based therapies
Hemophilia A is caused by reduced activity of a clotting protein called factor VIII (FVIII), which leads to symptoms like excessive and prolonged bleeding. Standard treatment involves factor replacement therapies, medications that work by providing a functional version of FVIII that can replace the missing or dysfunctional protein.
Precision’s Cryocheck assay measures FVIII activity, allowing for the assessment of both the naturally occurring protein and versions administered in replacement therapies. The test, in which FVIII triggers a color change that is read by a machine to determine protein activity, was cleared for use by the U.S. Food and Drug Administration (FDA) in 2020, making it the first commercially available FVIII test of its kind.
Recently, scientists have been working to develop antibody-based therapies for hemophilia A. The basic idea is to use an antibody that binds to other clotting proteins and mimics the activity of the missing FVIII. A notable benefit of this strategy is that, since it doesn’t actually use a version of the FVIII protein, it can be used to control bleeding in patients who have developed inhibitors, or neutralizing antibodies targeting FVIII that can reduce the efficacy of replacement therapies.
One such antibody-based therapy, Hemlibra (emicizumab-kxwh), is already approved in the U.S. to treat hemophilia A patients with or without inhibitors. Another antibody therapy, Mim8 (denecimig), is currently in clinical testing.
We want to ensure labs are ready and able to deliver accurate results when new treatments become available. And we want to make doing that as easy as possible for labs.
According to Precision, studies have shown that these antibody-based therapies may cause problems with FVIII lab tests. Essentially, some tests can’t distinguish between the activity of the therapeutic antibody or the FVIII protein itself. With the new updates, Precision is ensuring antibody-based therapies won’t interfere with the Cryocheck assay’s ability to assess FVIII activity.
Precision said it has already submitted data to the FDA showing that neither Hemlibra nor Mim8 interferes with the assay’s performance, and that the assay can accurately measure the potency of FVIII replacement therapies.
The updated test is expected to be commercially available by the end of the year in the U.S., as well as the European Union, the U.K., Australia, and New Zealand. Precision said it has resources in place to support labs switching from the original Cryocheck assay to the new upgrade.
“We want to ensure labs are ready and able to deliver accurate results when new treatments become available. And we want to make doing that as easy as possible for labs,” Empey said.
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