Precision BioLogic has received US Food and Drug Administration (FDA) 510(k) clearance for its CRYOcheck Chromogenic Factor IX assay for managing haemophilia B.

The Canada-based haemostasis diagnostic products developer has designed the haemophilia-related diagnostic product for use in clinical labs to identify factor IX (FIX) deficiency in human plasma and aid in the management of the bleeding disorder.

According to Precision BioLogic, the CRYOcheck Chromogenic Factor IX is the only FDA-cleared chromogenic FIX assay currently available in the market.

Precision BioLogic president and CEO Paul Empey said: “Precision BioLogic provides tools to help laboratory professionals make the best decisions, faster.

“Recognising 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 haemophilia tests.”

CRYOcheck Chromogenic Factor IX, which has been launched in the US following the FDA clearance, is formatted to meet the requirements of laboratories of any sizes, thereby increasing efficiency, reducing waste, and ensuring that the results are accurate, said the company.

It has been validated for use on current automated coagulation analysers, with a test range from 0-200% FIX activity using a standard curve.

Last year, CRYOcheck Chromogenic Factor IX was introduced in the UK, Australia, Canada, the European Union (EU), and New Zealand. It is the second chromogenic assay for haemophilia developed by Precision BioLogic.

The company’s Chromogenic Factor VIII assay for haemophilia A diagnosis was introduced in 2020 in North America, the EU, the UK, and Australasia.