The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to Augurex Life Sciences’ SPINEstat 14-3-3eta Autoantibody Multiplex Immunoassay Test, developed for the diagnosis of axial spondyloarthritis (axSpA).

Already approved in the UK and Canada, SPINEstat is designed to identify this autoimmune condition that causes chronic back pain, particularly among adults under 45 years of age. Often mistaken for common low back pain, axSpA frequently leads to misdiagnosis. Without timely and accurate diagnosis, the disease can progress to reduced spinal mobility and, in severe cases, spinal fusion.

SPINEstat works by measuring autoantibodies to the 14-3-3eta protein, offering a new approach to distinguish axSpA from mechanical back pain. Data presented at the American College of Rheumatology (ACR) Convergence Conference demonstrated the test’s high specificity and sensitivity, highlighting its ability to complement existing diagnostic methods that rely on clinical symptoms and imaging.

The test aims to support rheumatology specialists in making faster and more accurate diagnostic decisions, enabling earlier intervention and improved patient outcomes.

Augurex Life Sciences plans to collaborate closely with the FDA to accelerate the regulatory review process and bring SPINEstat to clinical practice in the United States. In parallel, the company is expanding test availability as Analyte Specific Reagents (ASRs) and General-Purpose Reagents (GPRs) under laboratory-developed testing frameworks. Broader commercial launches are also underway in the UK, Canada, and other international markets.

Commenting on the FDA’s recognition, Neil Klompas, CEO of Augurex Life Sciences, said: “Receiving FDA Breakthrough Designation for SPINEstat marks a major milestone for Augurex and an important step forward for patients living with inflammatory back pain. This recognition underscores the potential of SPINEstat to close a long-standing diagnostic gap by providing patients and physicians with an objective and specific tool to differentiate axSpA from mechanical back pain and ensure timely access to appropriate care.”