Augurex Life Sciences has received UK Conformity Assessed (UKCA) marking for its diagnostic blood test, JOINTstat, allowing the company to expand its presence in the British market for rheumatoid arthritis (RA) testing.
The UKCA designation follows the recent registration of JOINTstat with the UK Medicines and Healthcare products Regulatory Agency (MHRA) as an in vitro diagnostic (IVD).
This authorisation permits the use of JOINTstat across Great Britain, offering a new tool for healthcare providers and patients in diagnosing and managing rheumatoid arthritis.
The test identifies the 14-3-3eta protein, a significant biomarker associated with rheumatoid arthritis pathology, helping to detect patients who may experience more severe disease progression. This facilitates the possibility of earlier intervention with targeted treatment plans.
Various peer-reviewed publications back the test’s effectiveness, demonstrating reliable sensitivity and specificity in both early-phase and established rheumatoid arthritis cases. It also works alongside C-reactive protein (CRP) assessments to evaluate joint damage risk and treatment response.
Augurex Life Sciences claimed that over 1.5 million individuals have undergone clinical testing with JOINTstat, highlighting its adoption in North America.
The company said that the test has become a crucial component in clinical settings for the early detection of rheumatoid arthritis and the optimisation of treatment strategies. In Canada, JOINTstat is authorised by Health Canada, while in the US, it is offered as a laboratory-developed test (LDT).
Augurex Life Sciences CEO Neil Klompas said: “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.
“We are committed to bringing innovative solutions to healthcare professionals worldwide, and this milestone reinforces our dedication to improving patient outcomes through advanced diagnostics.”
