Augurex Life Sciences, a leader in autoimmune biomarker-based diagnostics, 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.
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.
