Augurex Announces UK Conformity Assessed (UKCA) Authorization for JOINTstat®, Expanding Access to Cutting-Edge Rheumatoid Arthritis Testing in Great Britain

• Augurex has received UK Conformity Assessed marking for JOINTstat^®, authorizing its use in Great Britain for rheumatoid arthritis diagnosis and management.
• JOINTstat^® is a well-established rheumatoid arthritis blood test in North America, approved by Health Canada and available in the U.S. as a laboratory-developed test.

VANCOUVER, British Columbia--(BUSINESS WIRE)--Augurex Life Sciences, a leader in autoimmune biomarker-based diagnostics, today announced that JOINTstat^®, the Company’s blood test for 14-3-3eta, has received UK Conformity Assessed (UKCA) marking. This milestone follows JOINTstat^®’s registration as an in vitro diagnostic (IVD) with the Medicines and Healthcare products Regulatory Agency (MHRA) last week.

With the UKCA conformity mark, JOINTstat^® is now registered for use in Great Britain, offering patients and physicians an advanced tool for diagnosing and managing rheumatoid arthritis (RA). The test detects the 14-3-3eta biomarker, which plays a key role in RA pathology and helps identify patients at risk of more severe disease, enabling earlier and more targeted treatment decisions. The utility of JOINTstat^® is supported by numerous peer-reviewed studies, demonstrating a robust pooled sensitivity and specificity across early and established RA. Clinical studies further highlight its complementarity with C-reactive protein (CRP) for monitoring joint damage risk and therapeutic response, reinforcing its value in RA management.

“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,” said Neil Klompas, CEO of Augurex. “We are committed to bringing innovative solutions to healthcare professionals worldwide, and this milestone reinforces our dedication to improving patient outcomes through advanced diagnostics.”

With over 1.5 million patients tested clinically to date, JOINTstat^® is well established in North America, where it has been integrated into clinical practice to aid in the early identification of RA and optimize treatment strategies. The test is available in Canada under Health Canada approval and available as a laboratory-developed test (LDT) in the United States. With UKCA authorization, Augurex continues its mission to support patients and physicians in the fight against inflammatory joint disease.

About Augurex

Augurex is a commercial stage diagnostics company dedicated to the early identification and diagnosis of autoimmune disorders, allowing treatment options to be optimized and personalized for patients around the world. Augurex’s lead diagnostic test which detects the 14-3-3eta protein, available as JOINTstat^® in Canada and Great Britain, is an important tool in the diagnosis and management of inflammatory diseases, including rheumatoid arthritis. The analyte specific reagents to detect 14-3-3eta are available for purchase and use by U.S. clinical laboratories as a component of diagnostic tests developed by such laboratories. The Anti-14-3-3eta Multiplex ASRs expand Augurex’s biomarker-informed diagnostic autoimmune solutions into axial spondyloarthritis, an autoimmune disease often misdiagnosed as low back pain, and which if untreated can lead to impaired spinal mobility and fusion of the vertebrae. Learn more about Augurex at www.augurex.com and follow us on Facebook, LinkedIn and X.