New Research Highlights Promising Advances in AxSpA Diagnosis
New data presented at the American College of Rheumatology (ACR) Convergence 2025 in October marked an important advance in the early detection of axial spondyloarthritis (axSpA). Researchers from Augurex Life Sciences shared results from several key studies (abstracts 2636, 2335, 0531) evaluating the Anti-14-3-3eta Multiplex test, a blood test designed to help physicians identify axSpA with greater accuracy and at an earlier stage.
The findings showed that the test can reliably distinguish inflammatory axSpA from mechanical back pain, addressing one of the most significant challenges in achieving a timely and accurate diagnosis.
Understanding the Anti-14-3-3eta Multiplex Test
The Anti-14-3-3eta Multiplex test detects autoantibodies to 14-3-3eta, a protein linked to inflammation and joint damage. This biomarker has been used for more than a decade in the diagnosis and monitoring of rheumatoid arthritis. New research now confirms that antibodies against this same protein also appear in people with axSpA, serving as disease-specific immune markers.
The test measures five specific autoantibodies to 14-3-3eta to generate a single score that reflects the likelihood of a patient having axSpA. Across multiple independent studies presented at ACR Convergence 2025 and other international rheumatology meetings, researchers found that anti-14-3-3eta autoantibodies were frequently detected in people with axSpA but rarely present in those with mechanical back pain or in healthy individuals, confirming their strong disease specificity.
Global Progress and Regulatory Milestones
The Anti-14-3-3eta Multiplex test is already approved in Canada and the United Kingdom under the name SPINEstat® as an in-vitro diagnostic, meaning it can be used in clinical laboratories to help doctors make diagnostic decisions. In the United States, it recently received FDA Breakthrough Device Designation, which recognizes both the significant unmet need in early axSpA diagnosis and the potential of this test to improve patient care. This designation is granted to promising medical technologies and helps accelerate their development, review, and availability to patients.
Why This Matters for Patients
Early diagnosis is essential to prevent irreversible spinal damage and improve quality of life. Many people with axSpA face long delays before receiving an accurate diagnosis, often undergoing years of imaging, lab testing, and referrals.
By adding a reliable new biomarker to existing tools such as C-reactive protein (CRP), HLA-B27 testing, and MRI, the Anti-14-3-3eta Multiplex test (SPINEstat®) may help doctors recognize inflammatory back pain earlier and distinguish it from mechanical causes. This could bring greater confidence in uncertain cases and help flag patients who may benefit from faster referral to a rheumatology specialist.
A faster and more accurate diagnosis can lead to earlier treatment, better symptom control, and improved long-term outcomes for people living with axSpA.
Looking Ahead
The Anti-14-3-3eta Multiplex test (SPINEstat®), expected to launch in the U.S. in 2026, represents an important advance in biomarker-based testing for spondyloarthritis. The data presented at ACR further build on previous research supporting its accuracy and clinical value, signaling continued progress toward closing the long-standing diagnostic gap in axSpA.
For patients and clinicians alike, these findings bring new hope for a future where identifying axSpA early becomes faster, simpler, and more precise.
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