Lumipulse Blood Biomarker Test for Diagnosis of Alzheimer Disease

Olivia Hilal, MD
Kenneth W. Lin, MD, MPH

American Family Physician. 2026;113(6):597-598.

Author disclosure: No relevant financial relationships.

OLIVIA HILAL, MD, Lancaster General Hospital Department of Family and Community Medicine, Lancaster, Pennsylvania

KENNETH W. LIN, MD, MPH, Lancaster General Hospital Department of Family and Community Medicine, Lancaster, Pennsylvania; AFP Deputy Editor

Address correspondence to Kenneth W. Lin, MD, MPH, at kenneth.lin@georgetown.edu.

Author disclosure: No relevant financial relationships.

  1. 1.US Food and Drug Administration. FDA news release. FDA clears first blood test used in diagnosing Alzheimer's disease. May 16, 2025. Accessed August 5, 2025. https://www.fda.gov/news-events/press-announcements/fda-clears-first-blood-test-used-diagnosing-alzheimers-disease
  2. 2.Lau K, Lin KW. Lumipulse G β-amyloid ratio test for the diagnosis of Alzheimer disease. Am Fam Physician. 2023;107(5):550-551.
  3. 3.US Food and Drug Administration. FDA permits marketing for new test to improve diagnosis of Alzheimer's disease [press release]. May 4, 2022. Accessed April 29, 2026. https://www.prnewswire.com/news-releases/fda-permits-marketing-for-new-test-to-improve-diagnosis-of-alzheimers-disease-301540093.html
  4. 4.Palmqvist S, Tideman P, Mattsson-Carlgren N, et al. Blood biomarkers to detect Alzheimer disease in primary care and secondary care. JAMA. 2024;332(15):1245-1257.
  5. 5.Alzheimer's Association. Alzheimer's Association clinical practice guideline on the use of blood-based biomarkers in the diagnostic workup of suspected Alzheimer's disease within specialized care settings. July 28, 2025. Accessed April 29, 2026. https://app.magicapp.org/#/guideline/nyO1Yj
  6. 6.Chen E. Major Alzheimer's group says some blood tests may be used in place of brain scans for diagnosis. STAT. July 29, 2025. Accessed April 29, 2026. https://www.statnews.com/2025/07/29/alzheimers-blood-tests-new-diagnosis-guidelines/
  7. 7.Evans RW. Complications of lumbar puncture. Neurol Clin. 1998;16(1):83-105.
  8. 8.Salloway S, Rowe C, Burns JM. Are blood tests for Alzheimer disease ready for prime time?. JAMA. 2024;332(15):1240-1241.
  9. 9.Alzheimer's Research Association. FDA cleared first blood test for Alzheimer's diagnosis: what should you know. June 5, 2025. Accessed April 29, 2026. https://www.alzra.org/blog/fda-cleared-first-blood-test-for-alzheimers-diagnosis/
  10. 10.Van Gool WA, Siebrand JAF, Brayne C, et al. Evidence gap in blood biomarkers for Alzheimer's disease. BMJ. 2025;390:e084781.

This series is coordinated by Natasha Pyzocha, DO, contributing editor.

A collection of Diagnostic Tests published in AFP is available at https://www.aafp.org/afp/diagnostic.

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