Augurex Life Sciences Granted FDA Breakthrough Designation for SPINEstat®, its First-in-Class Diagnostic Test for Axial Spondyloarthritis

Executive Summary

• The U.S. FDA has granted Breakthrough Device Designation to SPINEstat^® (14-3-3eta Autoantibody Multiplex Immunoassay Test), recognizing its potential to address a significant unmet need in the diagnosis of patients with axial spondyloarthritis (axSpA).
• SPINEstat^®, when combined with clinical findings, signs and symptoms consistent with axSpA (the most common being back pain), is intended to aid in the diagnosis of patients with axSpA.
• FDA Breakthrough Designation underscores Augurex’s commitment to patients by advancing novel autoimmune diagnostic solutions and improving early and accurate disease detection in areas of high unmet medical need.

VANCOUVER, British Columbia--(BUSINESS WIRE)--Augurex Life Sciences Corp., a leader in the development of autoimmune diagnostic tests, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the SPINEstat^® 14-3-3eta Autoantibody Multiplex Immunoassay Test (approved as SPINEstat^® in Canada and the United Kingdom) for the diagnosis of patients with axial spondyloarthritis (axSpA). The designation recognizes the potential of this first-in-class diagnostic test to address a large unmet need in the early and accurate differentiation of axSpA within the broader chronic back pain population.

AxSpA is a chronic and degenerative autoimmune disease that causes persistent back pain in adults typically under the age of 45 and affects millions of people worldwide. Despite its prevalence, patients often face significant diagnostic delays averaging seven to ten years, as many patients are misdiagnosed with mechanical back pain, resulting in delayed therapeutic intervention and irreversible spinal damage.

SPINEstat^® is a multiplex immunoassay that measures autoantibodies to the 14-3-3eta protein. In recent data presented at the American College of Rheumatology (ACR) Convergence conference, SPINEstat^® demonstrated high specificity and sensitivity in differentiating axSpA from mechanical back pain. By complementing existing diagnostic tools, as well as signs, symptoms, and clinical findings, SPINEstat^® aids in improved clinical decision-making and expedited referrals to rheumatology care, with the goal of reducing the uncertainty and extended diagnostic delay facing many back pain patients who may be living with axSpA.

“Receiving FDA Breakthrough Designation for SPINEstat^® marks a major milestone for Augurex and an important step forward for patients living with inflammatory back pain,” said Neil Klompas, Chief Executive Officer of Augurex Life Sciences. “This recognition from the FDA underscores the potential of SPINEstat^® to close a long-standing diagnostic gap for this debilitating condition by providing patients and physicians with a new objective and specific tool to differentiate axSpA from mechanical back pain and access the appropriate medical care.”

Augurex looks forward to working with the FDA to advance the regulatory review of SPINEstat^® while expanding the availability as ASRs and GPRs under the Laboratory Developed Test in the U.S., concurrent with broader commercial launches in Canada, the UK and the rest of the world.

Augurex remains focused on expanding access to innovative biomarker-based diagnostics that enable earlier and more accurate detection of autoimmune and inflammatory diseases, including axSpA.

About Augurex

Augurex is a commercial-stage diagnostics company dedicated to the early identification and diagnosis of autoimmune disorders. Augurex’s first diagnostic test, which detects the 14-3-3eta protein, is approved as JOINTstat^® in Canada and Great Britain, and is available as a Laboratory Developed Tests through major US based reference labs. 14-3-3eta is an important tool in the diagnosis and management of inflammatory diseases, including rheumatoid arthritis. The Anti-14-3-3eta Multiplex ASRs, approved 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.