The Future of IVD Biomarkers—Alzheimer’s Blood Tests Lead the Way.

Published on 2026-08-27 19:01:35 by giendi

The latest JAMA study reinforces a major shift underway in the in vitro diagnostics (IVD) industry: blood-based biomarkers are becoming clinically reliable tools for diagnosing complex diseases previously dependent on specialized imaging or CSF testing.

🔬 Why This Matters for IVD Innovation

The validation of p tau217 and the APS2 algorithm marks a breakthrough in biomarker development. These assays deliver:

• High diagnostic accuracy (88–92%)

• Scalable testing for primary care

• Improved diagnostic confidence vs. standard clinical evaluation

• Real-world feasibility with biweekly prospective testing

This is exactly the type of biomarker evolution the IVD industry needs—high-performance assays that can be deployed broadly, reduce diagnostic delays, and support emerging therapeutic pathways such as anti-amyloid immunotherapies.

🧪 Vendors Currently Supplying Alzheimer’s Blood Biomarker Tests

Based on the study and current market availability, the following companies provide validated or emerging AD blood-based assays:

  1. C2N Diagnostics

    • PrecivityAD2 (APS2) blood test

    • Mass spectrometry-based p tau217 and Aβ42:Aβ40

    • Featured prominently in the JAMA study

  2. Fujirebio

    • Lumipulse platform (CSF Aβ42, Aβ40, p tau assays)

    • FDA cleared CSF assays; expanding into plasma biomarkers

  3. Quanterix (Simoa platform)

    • Ultra sensitive immunoassays for p tau217, p tau181, Aβ42/40

    • Widely used in research and early clinical adoption

  4. Roche Diagnostics

    • Elecsys AD biomarkers (CSF today; plasma assays in development)

  5. Lilly (in collaboration with academic labs)

    • Developed the p tau217 assay used in the study’s CSF comparator

    • Plasma versions expected as part of therapeutic-linked diagnostics

  6. Quest Diagnostics & Labcorp

    • Offering early access AD blood biomarker panels (p tau, Aβ ratios)

    • Not yet fully standardized but rapidly expanding

💡 GRN IVD Consulting Perspective

The Alzheimer’s biomarker landscape is a model for how next-generation biomarkers will transform IVD markets across neurology, oncology, cardiology, and infectious disease. The combination of high-accuracy plasma markers, algorithmic scoring, and broad accessibility is the future of diagnostic strategy.

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