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SPINEstat® (Anti-14-3-3eta Multiplex) is a first-in-class biomarker test for Axial Spondyloarthritis.

What is Axial Spondyloarthritis?

Axial Spondyloarthritis (axSpA) is a chronic inflammatory disease affecting the spine and sacroiliac joints, causing pain, stiffness and joint damage.
 

Burden of Diagnostic Delay

AxSpA imposes a significant burden on patients, impacting physical function, mental health, and work productivity. Diagnosis is often delayed by 7-10 years due to the absence of reliable biomarkers, with many cases misdiagnosed as chronic low back pain. Early detection is critical for preventing long-term damage and improving patient outcomes.1

Average years diagnostic delay4

Had trouble getting out of bed2

Were affected by some form of psychological distress2

Reported difficulty finding a job due to their disease2

Anti-14-3-3eta Multiplex addresses critical gaps in patient care to improve outcomes

Streamlined Diagnostic Process

Aids in the early and accurate diagnosis of axSpA, reducing the 7-10 year average time to diagnosis.

Complementary to Imaging

Offers diagnostic support alongside traditional imaging.

Clinical Confidence

Enables evidence-based decisions, leading to more timely and appropriate treatment plans.

Improved Outcomes

Anti-14-3-3eta Multiplex aids in earlier detection and intervention of axSpA, potentially preventing long-term spinal damage.

Anti-14-3-3eta Multiplex is highly sensitive and specific for early diagnosis of axSpa

Early and Accurate Diagnosis

Anti-14-3-3eta Multiplex is highly sensitive (76%) and highly specific (74%) to enable differentiation between axSpA and chronic low back pain.3

Complementary to CRP

Combined with CRP, the test can identify 90% of axSpA patients, improving diagnostic accuracy.4

HLA-B27 Independent

Provides diagnostic value even in patients who are negative for traditional markers like HLA-B27.4

Anti-14-3-3eta Multiplex is highly sensitive and highly specific for early diagnosis of axSpA

Anti-14-3-3eta Multiplex is now available for early access in Knoxville, Tennessee, through our partnership with New Day Diagnostics as a laboratory-developed test (LDT).

    Anti-14-3-3eta Multiplex is the only diagnostic test for axSpA

    Anti-14-3-3eta Multiplex is a novel diagnostic test that detects autoantibodies against the normally intracellular 14-3-3eta protein, a well-established biomarker in autoimmune rheumatologic disorders.

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    References

    References:

    1. Poddubnyy D, Garrido-Cumbrera M, Sommerfleck F, et al. POS0689. Diagnostic delay in patients included in the International Map of Axial Spondyloarthritis: associations with geographic, socio-demographic and disease-related factors. Annals of the Rheumatic Diseases. 2023;82:628-629
    2. The burden of axial spondyloarthritis: A global patient perspective. International Map of Axial Spondyloarthritis (IMAS) Report. 2024, Jan. https://asif.info/imas/imas-global-report
    3. Marotta A, Maksymowych WP, Wichuk S, Sidhu N. P54 Novel Diagnostic 14-3-3η Auto-Antibody Marker for Axial Spondyloarthritis: A Longitudinal Study. Fourteenth International Congress on Spondyloarthritides. Clin Exp Rheumatol. 2024.
    4. Marotta A, Maksymowych WP, Wichuk S, Sidhu N. POS1094 Autoantibodies to 14-3-3η in Axial Spondyloarthritis. Annals of the Rheumatic Diseases. 2024;83:892-893.

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