Precision BioLogic Inc., a company specializing in hemostasis diagnostics, recently announced that they have received the requisite clearance from the U.S. Food and Drug Administration (FDA) to launch and market their CRYOcheck™ Chromogenic Factor IX assay.

CRYOcheck is a chromogenic screening test designed to help determine factor IX (FIX) activity levels in the plasma of individuals with hemophilia B who are two years of age or older. According to a new press release, this assay is intended for use by clinical labs to better identify and monitor FIX deficiency in patients and represents the only FDA-cleared chromogenic FIX assay on the market that “answers a growing demand for such tests.”

"Precision Biologic provides tools to help laboratory professionals make the best decisions, faster," says Paul Empey, the company’’s President and CEO. "Recognizing the need for FDA-cleared chromogenic assays, Precision Biologic developed CRYOcheck Chromogenic Factor IX to meet the needs of today's clinical laboratories. 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."

Read the full press release.

Also read NHF’s Medical and Scientific Advisory Council (MASAC) Document #228 –

MASAC Statement Regarding Use of Various Clotting Factor Assays to Monitor Factor Replacement Therapy for added reference. [Important Editor’s NOTE: Despite this MASAC statement having been released a few years prior to availability of this latest FIX assay, general information about chromogenic assays is provided, along with greater context on both the utility and challenges associated with their use in the U.S.]

Additional Resource:

Peyvandi, F, Kenet, G, Pekrul, et al. Laboratory testing in hemophilia: Impact of factor and non-factor replacement therapy on coagulation assays. J Thromb Haemost. 2020; 18: 1242– 1255.

Source: Cision (PR Newswire) January 5, 2023