Precision BioLogic, a developer of hemostasis diagnostic products, announced FDA 510(k) clearance and the launch of its new CRYOcheck Chromogenic Factor IX assay in the U.S.
The latest in Precision BioLogic’s family of hemophilia-related diagnostic products, CRYOcheck Chromogenic Factor IX is intended for use by clinical labs to identify factor IX (FIX) deficiency in human plasma and aid in the management of hemophilia B. It is the only FDA-cleared chromogenic FIX assay on the market and answers a growing demand for such tests.
According to the National Hemophilia Foundation (NHF), advancements in therapies to treat hemophilia have, in some cases, revealed limitations of current one-stage clotting assays to effectively monitor replacement therapy. To address these limitations, NHF’s Medical and Scientific Advisory Council recommends the addition of cleared chromogenic assays to testing panels in clinical labs.1
“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.”
CRYOcheck Chromogenic Factor IX is validated for use on current automated coagulation analyzers, with a test range from 0–200% FIX activity using one standard curve*, and formatted to meet the needs of any size laboratory, increasing efficiency, reducing wastage, and ensuring accuracy of results. Like all of Precision BioLogic’s products, its unique frozen format allows for fast and easy preparation.
CRYOcheck Chromogenic Factor IX launched in Canada, the EU, UK, Australia, and New Zealand in 2022. It is Precision BioLogic’s second hemophilia-related chromogenic assay. In 2020, the company successfully launched its Chromogenic Factor VIII assay for the diagnosis of hemophilia A throughout North America, the EU, UK, and Australasia.
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* May vary based on the instrumentation in use.
1 National Hemophilia Foundation. MASAC Document #228. MASAC Statement Regarding Use of Various Clotting Factor Assays to Monitor Factor Replacement Therapy. Available at https://www.hemophilia.org/sites/default/files/document/files/masac-228.pdf. Accessed on January 3, 2023.
