Augurex Life Sciences Corp, a developer of autoimmune diagnostic tests, announced on Tuesday that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its SPINEstat 14-3-3eta Autoantibody Multiplex Immunoassay Test for the diagnosis of axial spondyloarthritis (axSpA).

This designation recognises SPINEstat's potential to address a major unmet need in identifying axSpA among patients with chronic back pain.

AxSpA is a degenerative autoimmune disease that affects millions worldwide, often leading to diagnostic delays averaging seven to ten years. SPINEstat measures autoantibodies to the 14-3-3eta protein and, when combined with clinical findings, helps differentiate axSpA from mechanical back pain with high specificity and sensitivity.

The test aims to accelerate diagnosis and referral to rheumatology care, reducing the risk of irreversible spinal damage from delayed treatment. Augurex presented supporting data at the American College of Rheumatology Convergence conference, highlighting SPINEstat's diagnostic accuracy.

CEO Neil Klompas said that the designation marks a key milestone for Augurex and a step forward in improving early, accurate disease detection. The company plans to collaborate with the FDA to advance SPINEstat's regulatory review while expanding availability across North America, the United Kingdom, and global markets.