Augurex Announces UKCA Authorization for SPINEstat™, Expanding Access to a First-in-Class Diagnostic Blood Test for Axial Spondyloarthritis to Great Britain

• SPINEstat™, a novel, first-in-class diagnostic blood test for axial spondyloarthritis (axSpA), has received UKCA marking and is now listed as an IVD in the United Kingdom. This milestone expands access to an important new tool that addresses the long-standing diagnostic challenges associated with axSpA.
• AxSpA is an inflammatory autoimmune condition of the spine, often misdiagnosed as persistent lower back pain for 7–10 years before accurate detection. Earlier diagnosis is essential to prevent irreversible spinal damage and to improve outcomes.
• SPINEstat™ offers physicians an objective, clinically validated biomarker to support early and accurate axSpA diagnosis, marking a major advancement in autoimmune diagnostics across the UK.

VANCOUVER, British Columbia--(BUSINESS WIRE)--Augurex Life Sciences, a leader in autoimmune biomarker-based diagnostics, today announced that SPINEstat™ has received UK Conformity Assessed (UKCA) marking by the Medicines and Healthcare products Regulatory Agency (MHRA), authorizing the blood test for clinical use and listing it as an in vitro diagnostic (IVD) in Great Britain.

SPINEstat™ is a blood test that detects auto-antibodies to the 14-3-3eta protein and provides physicians with a new objective tool to assist in the diagnosis of axial spondyloarthritis (axSpA), a chronic inflammatory disease that commonly presents as persistent back pain. Symptoms often begin before the age of 45 and can lead to irreversible spinal fusion and reduced mobility if left untreated.

With a well-documented average delay of 7–10 years between the onset of symptoms and diagnosis, many patients with axSpA can endure years of back pain coupled with disease progression and disability. SPINEstat™ can help bridge this diagnostic gap by assisting physicians in differentiating axSpA from other forms of mechanical or chronic back pain.

“The MHRA authorization of SPINEstat™ represents a major step forward in improving the diagnostic pathway for axSpA in the UK,” said Neil Klompas, CEO of Augurex. “As we grow our global footprint, this milestone reflects our commitment to expand access of advanced precision diagnostics for autoimmune diseases. By enabling earlier detection of this debilitating condition, SPINEstat™ empowers healthcare professionals to intervene sooner and improve outcomes for patients.”

With this UKCA authorization, Augurex continues its mission to improve autoimmune disease detection globally, equipping physicians with next-generation diagnostic tools that are evidence-based and clinically actionable.

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, available as SPINEstat™ in Canada and Great Britain, expands 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.