NEW YORK – Vancouver, Canada-based autoimmune disorder diagnostics developer Augurex announced on Monday that it has obtained UK Conformity Assessed (UKCA) Authorization for a test to diagnosis and manage rheumatoid arthritis.
Called JointStat, the assay detects the protein biomarker 14-3-3eta in blood in order to diagnose the progressive disease and also identify patients who are potentially at risk of more severe disease.
"This UKCA marking is an important step in expanding global access to JointStat, providing a path for patients and clinicians in the UK to access a valuable tool to support the diagnosis and management of rheumatoid arthritis," Neil Klompas, CEO of Augurex, said in a statement.
JointStat has previously been approved by Health Canada, the firm said, and it was also recently registered as an in vitro diagnostic (IVD) with the UK's Medicines and Healthcare products Regulatory Agency (MHRA).
The test is available in the US as a laboratory developed test. Last year, Augurex signed a nonexclusive agreement with Quest Diagnostics to offer its 14-3-3eta test as an LDT.
Augurex claims that more that 1.5 million patients have been clinically tested to date with JointStat.