Several leading diagnostics companies and laboratories are providing or developing plasma pTau blood biomarker tests (especially pTau217) for human clinical assessment of Alzheimer’s disease:

1. Quanterix / Lucent Diagnostics

  • Their LucentAD® product line includes a high-accuracy p-Tau 217 blood test for Alzheimer’s diagnosis, leveraging the ultra-sensitive Simoa® technology and specialized antibodies.
  • This test has been clinically validated and is available through licensed medical providers.

2. ARUP Laboratories

  • ARUP now offers a pTau217 blood test, validated with samples from major clinical trials. The test is performed on Quanterix’s Simoa platform using antibody technology licensed from Eli Lilly.
  • ARUP is recognized for integrating recent research biomarkers into clinical diagnostics.

3. Roche Diagnostics

  • Roche, in partnership with Eli Lilly, is developing the Elecsys® pTau217 plasma biomarker test. It has received FDA Breakthrough Device Designation and is in advanced stages of regulatory clearance in the U.S. and Europe.
  • Roche is a global leader in clinical diagnostics with broad implementation capabilities.

4. Fujirebio

  • Makers of Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio test, which recently received marketing clearance from the FDA for early detection of amyloid plaques in Alzheimer’s disease.
  • Fujirebio is collaborating with Biogen and Beckman Coulter to advance blood-based tau pathology diagnostics.

5. Quest Diagnostics

  • Their AD-Detect™ suite now offers p-tau217 plasma biomarker blood testing for Alzheimer’s disease risk assessment, available via physician order at nationwide service centers.

6. ALZpath

  • ALZpath specializes in early Alzheimer’s blood biomarkers and has developed proprietary pTau217 antibodies that are licensed to other diagnostic labs and companies. Direct testing branded as ALZpath Dx is also available, supporting both research and clinical deployment.

7. Labcorp

  • Labcorp offers pTau217 and related Alzheimer’s blood biomarker testing as part of a robust neurology portfolio for clinical use.

8. Mayo Clinic Laboratories

  • Mayo Clinic provides a blood (plasma) pTau217 test as part of its clinical diagnostic catalog for Alzheimer’s evaluation.

9. Spear Bio

  • Spear Bio has received FDA breakthrough device designation for its novel pTau217 blood test, advancing scalable biomarker solutions for early Alzheimer’s diagnosis.

These providers use advanced platform technologies and antibody reagents (often licensed from specialist developers like ALZpath and Eli Lilly) to commercialize and scale pTau blood testing for clinical, research, and pharma trial use. The field continues to expand rapidly as blood biomarkers become increasingly integrated into dementia workups for early and accurate detection.

  1. https://www.quanterix.com/press-releases/quanterix-launches-high-accuracy-p-tau-217-blood-biomarker-test-to-aid-physician-diagnosis-of-alzheimers-disease/
  2. https://www.lucentdiagnostics.com/tests/lucentad-p-tau-217/
  3. https://www.quanterix.com/breaking-ground-in-alzheimers-diagnosis-simoa-p-tau-217-blood-test-receives-fda-breakthrough-device-designation/
  4. https://www.aruplab.com/news/04-21-2025/arup-launches-ptau-217-test-detect-alzheimers-disease
  5. https://diagnostics.roche.com/us/en/news-listing/2024/roche-granted-fda-breakthrough-device-designation-ptau217-blood-test-support-earlier-alzheimers-disease-diagnosis.html
  6. https://www.roche.com/media/releases/med-cor-2025-07-23b
  7. https://diagnostics.roche.com/us/en/products/product-category/neurology/alzheimers-disease.html
  8. https://www.fujirebio.com/en-us/news-events/fujirebio-receives-marketing-clearance-for-lumipulser-g-ptau-217bamyloid-142-plasma-0
  9. https://www.fda.gov/news-events/press-announcements/fda-clears-first-blood-test-used-diagnosing-alzheimers-disease
  10. https://www.fujirebio.com/en-us/Alzheimer
  11. https://newsroom.questdiagnostics.com/2024-04-22-Quest-Diagnostics-Adds-p-tau217-Blood-Biomarker-Testing-to-Suite-of-Services-Designed-to-Assess-Risk-and-Help-Aid-Diagnosis-of-Alzheimers-Disease
  12. https://alzpath.bio
  13. https://www.brightfocus.org/resource/alzheimers-blood-tests-how-do-they-work-and-should-you-request-one/
  14. https://www.labcorp.com/treatment-areas/neurology/conditions/neurodegenerative/alzheimers
  15. https://www.labcorp.com/treatment-areas/neurology/clinical-testing/ptau217betaamyloid42ratio
  16. https://www.mayocliniclabs.com/test-catalog/Overview/621635
  17. https://spear.bio/blog/2025/01/13/spear-bio-secures-fda-breakthrough-device-designation-for-its-novel-ptau-217-blood-test-advancing-scalable-solutions-for-early-alzheimers-disease-diagnosis/