The multiplex immunoassay measures autoantibodies to the 14-3-3eta protein and aims to reduce diagnostic delays that currently average seven to 10 years.
The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to SPINEstat, a multiplex immunoassay test for diagnosing axial spondyloarthritis (axSpA), marking a potential advance in addressing significant diagnostic delays for this chronic autoimmune condition.
Developed by Augurex Life Sciences Corp, the 14-3-3eta Autoantibody Multiplex Immunoassay Test measures autoantibodies to the 14-3-3eta protein and is intended to aid in diagnosing patients with axSpA when combined with clinical findings, signs, and symptoms consistent with the condition.
The FDA designation recognizes the test’s potential to address an unmet need in early and accurate differentiation of axSpA within the broader chronic back pain population. AxSpA is a chronic and degenerative autoimmune disease causing persistent back pain in adults typically under age 45, affecting millions worldwide.
Addressing Diagnostic Delays
Current diagnostic challenges are substantial, with patients facing diagnostic delays averaging seven to 10 years, notes a release from Augurex Life Sciences Corp. Many patients are misdiagnosed with mechanical back pain, resulting in delayed therapeutic intervention and irreversible spinal damage.
Recent data presented at the American College of Rheumatology Convergence conference showed SPINEstat demonstrated high specificity and sensitivity in differentiating axSpA from mechanical back pain. The test is designed to complement existing diagnostic tools as well as signs, symptoms, and clinical findings to aid in improved clinical decision-making and expedited referrals to rheumatology care.
“Receiving FDA Breakthrough Designation for SPINEstat marks a major milestone for Augurex and an important step forward for patients living with inflammatory back pain,” says Neil Klompas, chief executive officer of Augurex Life Sciences, in a release. “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.”
Regulatory and Commercial Plans
The Vancouver-based company plans to work with the FDA to advance regulatory review of SPINEstat while expanding availability as analyte-specific reagents and general-purpose reagents under Laboratory Developed Tests in the US. This will run concurrent with broader commercial launches in Canada, the UK, and other international markets.
SPINEstat is already approved in Canada and the United Kingdom. The company says it remains focused on expanding access to innovative biomarker-based diagnostics that enable earlier and more accurate detection of autoimmune and inflammatory diseases.
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