Augurex Gains UKCA Approval for SPINEstat™ Axial Spondyloarthritis Test
Augurex Life Sciences, a pioneer in autoimmune biomarker diagnostics, announced that its SPINEstat™ blood test has received UK Conformity Assessed (UKCA) marking from the Medicines and Healthcare products Regulatory Agency (MHRA). This certification authorizes SPINEstat™ for clinical use and officially recognizes it as an in vitro diagnostic (IVD) in Great Britain, expanding access to this first-in-class diagnostic tool for axial spondyloarthritis.
Augurex Life Sciences, a leading company in autoimmune biomarker-based diagnostics, has announced that its innovative blood test, SPINEstat™, has received UK Conformity Assessed (UKCA) marking by the Medicines and Healthcare products Regulatory Agency (MHRA). This important regulatory milestone authorizes the use of SPINEstat™ as a clinical diagnostic tool and officially registers it as an in vitro diagnostic (IVD) in Great Britain.
SPINEstat™ is a cutting-edge blood test designed to assist in the diagnosis of axial spondyloarthritis (axSpA)—a chronic, progressive autoimmune disease that commonly presents as long-term back pain, particularly in younger adults. AxSpA often goes undiagnosed for years, as its early symptoms are easily mistaken for common mechanical or chronic back pain, leading to delayed treatment and avoidable disease progression.
A Game-Changer for AxSpA Diagnosis
SPINEstat™ detects auto-antibodies to the 14-3-3eta protein, a biomarker associated with autoimmune activity. By identifying this specific immune response in the bloodstream, the test offers clinicians an objective, biomarker-based method to support the diagnosis of axSpA. This is a significant advancement in a disease area where diagnosis is often subjective and based primarily on symptoms and imaging.
Axial spondyloarthritis is a debilitating inflammatory condition that primarily affects the spine and sacroiliac joints. It typically manifests before the age of 45, with early symptoms such as persistent back pain, stiffness, and fatigue. If left untreated, the disease can lead to irreversible spinal fusion, resulting in severe loss of mobility and quality of life.
What makes axSpA particularly challenging is the 7 to 10-year average delay between symptom onset and formal diagnosis. During this time, patients may suffer worsening pain and inflammation, irreversible joint damage, and even misdiagnosis, leading to improper or delayed treatment. SPINEstat™ can help bridge this diagnostic gap by offering a simple, blood-based method to distinguish axSpA from other causes of back pain.
Advancing Precision Medicine in Autoimmune Diseases
“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 expanding access to 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.”
This approval builds on Augurex’s mission to revolutionize autoimmune disease diagnosis through the use of evidence-based, biomarker-informed tools. SPINEstat™, now authorized in both Canada and Great Britain, is part of Augurex’s growing portfolio aimed at enhancing diagnostic precision and promoting timely, personalized care.
Addressing an Unmet Clinical Need
Current diagnostic approaches for axSpA rely heavily on a combination of clinical evaluation, imaging (often MRI), and subjective symptom reporting. However, these methods may not be sensitive enough to detect early or non-radiographic forms of the disease. The addition of a quantitative blood test like SPINEstat™ provides a valuable tool in the early detection and classification of axSpA, potentially enabling earlier treatment initiation and improved disease management.
As a non-invasive, easily administered test, SPINEstat™ also has the potential to streamline the diagnostic process across a range of healthcare settings—from specialist rheumatology clinics to primary care—broadening access and reducing the burden on healthcare systems.
About Augurex Life Sciences
Augurex is a commercial-stage diagnostics company dedicated to the early detection and diagnosis of autoimmune disorders, enabling clinicians to optimize and personalize treatment strategies for patients worldwide. The company’s technology is built around the 14-3-3eta protein, a clinically validated biomarker that plays a key role in inflammatory and autoimmune processes.
Augurex’s lead diagnostic test, JOINTstat®, is widely used in Canada and Great Britain for the diagnosis and management of rheumatoid arthritis. In the U.S., analyte-specific reagents for 14-3-3eta detection are available for laboratory-developed tests used by clinical laboratories.
With the introduction of SPINEstat™, Augurex is expanding its biomarker-based diagnostic platform to address axial spondyloarthritis—an often overlooked and underdiagnosed condition. The company’s broader goal is to improve access to precise, clinically actionable diagnostics across the spectrum of autoimmune diseases.
