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Blood Studies for Cardiovascular System I: Cardiac Biomarkers01:20

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Cardiac biomarkers are enzymes, proteins, and hormones released into the blood when cardiac cells are injured. They are powerful tools for triaging.
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Dried Blood Spot Collection of Health Biomarkers to Maximize Participation in Population Studies
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Biomarkers.

Yan Helen Hu1, Elizabeth Somers1, Miyuru Amarapala2

  • 1Eisai Inc., Nutley, NJ, USA.

Alzheimer'S & Dementia : the Journal of the Alzheimer'S Association
|December 25, 2025
PubMed
Summary

Blood-based biomarkers (BBM) show strong diagnostic performance for Alzheimer's Disease (AD), correlating with PET and CSF tests. Evidence supports their clinical adoption for AD diagnosis and selecting patients for targeted therapies.

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Area of Science:

  • Neurology
  • Biomarker Research
  • Diagnostic Medicine

Background:

  • Alzheimer's Disease (AD) diagnosis relies on established but invasive methods like PET and CSF.
  • Emerging blood-based biomarkers (BBM) offer accessible, affordable, and less invasive alternatives for AD pathology detection.
  • Understanding the evidence for BBM validity and utility is crucial for guiding clinical decisions and therapy selection.

Purpose of the Study:

  • To systematically review and characterize the clinical and non-clinical evidence for established and emerging AD BBM.
  • To assess the analytical validity (AV), clinical validity (CV), clinical utility (CU), and non-clinical utility (NCU) of AD BBM.
  • To evaluate the diagnostic performance and clinical impact of BBM in early AD detection and management.

Main Methods:

  • A structured literature search (Medline/PubMed) identified 330 relevant articles (2018-2024) using the PICOS framework.
  • Studies evaluated plasma biomarkers including β-amyloid (Aβ), Tau (p-Tau 217), GFAP, and APOE in adults with mild cognitive impairment or mild dementia due to AD.
  • Evidence quality was assessed using an adapted Hayes Rating System.

Main Results:

  • Publications on AD BBM have increased exponentially, with over 200 studies by late 2024.
  • Most studies focused on CV, with a growing number demonstrating CU and NCU, including impact on management and cost-utility.
  • Research shows increasing interest in diverse populations and at-risk cognitively unimpaired adults.

Conclusions:

  • BBM demonstrate strong diagnostic performance for AD, correlating with PET and CSF, and show significant clinical utility and economic value.
  • The evidence supports the clinical adoption of BBM for routine AD diagnosis and patient selection for targeted therapies.
  • Payers are encouraged to evaluate reimbursement for BBM to improve patient access in AD diagnosis and management.