Blood-Based Biomarker Workgroup

The Global CEO Initiative on Alzheimer’s Disease is leading a global effort to prepare for widespread adoption of blood-based biomarkers in clinical practice to enable a more simple, timely, and accurate Alzheimer’s diagnosis. 

About

Mission

Disease-modifying treatments for early Alzheimer's may slow progression of the disease. Eligibility for these novel treatments is contingent on confirming biomarker positivity for Alzheimer’s. 

Clinicians expect major difficulties in providing biomarker testing for a large number of patients if only brain imaging via positron emission tomography or cerebrospinal fluid assays are used. Because blood collection does not require highly specialized training, blood-based biomarkers could greatly reduce the burden of biomarker testing. 

Successful deployment of blood-based biomarkers will improve patient access to appropriate care. To this aim, we have convened a diverse group of stakeholders that will prepare health-care systems for widespread adoption of blood-based biomarkers that support a more simple, timely, and accurate Alzheimer’s diagnosis in clinical practice.

 

Overview

Over 80 stakeholders spanning academia, healthcare, advocacy, industry, non-profit, and venture capital have joined CEOi’s global effort to prepare for widespread adoption of blood-based biomarkers in clinical practice to enable a more simple, timely, and accurate Alzheimer’s  diagnosis.

In early 2023, the Workgroup kicked off three workstreams that will provide recommendations and educate on the real-world use of blood-based biomarkers and how to effectively implement these technologies in clinical practice to improve the patient journey. 

  • Workstream A: Define the appropriate use cases of blood-based biomarkers and define minimum viable test specifications​ for blood tests
  • Workstream B: Provide actionable recommendations on implementing blood-based biomarkers in clinical practice ​
  • Workstream C: Identify educational gaps on blood-based biomarkers and develop resources that directly address those needs 

Learnings from the Blood-Based Biomarker Workgroup will be used as a blueprint for accelerated adoption outside of the US and for other disruptive diagnostic technologies in Alzheimer’s disease ​.

Leadership

Convener 

The Global CEO Initiative on Alzheimer’s Disease (CEOi)

Steering Committee

Emily Scholler, CEOi

Drew Holzapfel, CEOi

John Dwyer, Global Alzheimer’s Platform Foundation  

Jim Murray, Davos Alzheimer's Collaborative

Daryl Jones, Eisai

Sasha Bozeat, Roche Diagnostics 

Workstream A Leads

Suzanne Schindler, Washington University

Oskar Hansson, Lund University  

Workstream B Leads

Michelle Mielke, Wake Forest University

Chi Udeh-Momoh, Imperial College London

Workstream C Leads 

Ara Khachaturian, The Campaign to Prevent Alzheimer's Disease

Joan Weiss, Health Resources and Services Administration 

 

Workstream A

Workstream A Leads

Suzanne Schindler, Washington University

Oskar Hansson, Lund University  

Core Objective 

Workstream A will clarify the contexts of use for blood-based biomarkers tests that serve to triage symptomatic individuals that might be at risk, and for blood tests that confirm the presence/absence of Alzheimer’s disease.

Outputs 

  • Create detailed summaries or target product profiles for blood tests that describe the following:​
    • The value of blood-based biomarkers as tools for triaging and confirmation of pathology​
    • The characteristics of blood-based biomarker performance needed for different uses
    • Minimum clinical blood test performance by use case
  • Publish recommendations for the use of blood-based biomarkers in clinical practice ​​

Workstream B

Workstream B Leads

Michelle Mielke, Wake Forest University

Chi Udeh-Momoh, Imperial College London

Core Objective 

Provide guidance on implementing blood-based biomarkers in clinical practice. 

Outputs 

  • Leverage recommendations from Workstream A to identify processes that must be implemented to accelerate adoption of blood-based biomarkers into primary and specialty care sites ​
  • Identify and address barriers to adoption 
  • Publish actionable recommendations for implementing blood-based biomarkers to be adapted to different sites  

Workstream C

Workstream C Leads

Ara Khachaturian, The Campaign to Prevent Alzheimer's Disease

Joan Weiss, Health Resources and Services Administration 

Core Objective 

Develop resources that address that address educational gaps on blood-based biomarkers. 

Outputs 

Produce and disseminate publications and other supplementary materials that address the following educational needs:

  • Differences between an in vitro diagnostic and lab-developed blood test including reimbursement considerations​
  • Meaningful differences in performance between blood tests, cerebrospinal fluid tests, and positron emission tomography imaging 
  • Implications for practicing clinicians, specialists, other health care workers in using blood tests ​
  • Training on the diagnostic criteria, when to order a blood test, and how to interpret the findings for professionals, patients, families, and caregivers

Join Us

For more information or to become involved in the Blood-Based Biomarker Workgroup, please email Emily Scholler [email protected]

Sponsors

Eisai
Lilly logo
Gates Ventures logo
Davos Alzheimer’s Collaborative
Global Alzheimer’s Platform Foundation Logo

Contributing Organizations

Women's Brain Project logo
Banner Health logo
Butler University logo
C2N Logo
Cleveland Clinic Logo
DigiCare Realized Logo
Eli Lilly
Federal University of Sao Paulo Logo
Fujirbio Logo
Gates Venture Logo
Gerontological Society of America Logo
Health Resources and Services Administration (U.S. Department of Health and Human Services) Logo
Imperial College London UK Logo
Indiana University Logo
Ixico logo
Linus Health Logo
Lund University Logo
Mayo Clinic Logo
Mount Sinai Logo
Neo Auvra Logo
Neurovision Logo
Oxford Brain Diagnostics Logo
Progressive Medical Research Logo
RetiSpec Logo
Roche Logo
Rowan Medicine Logo
Stanford University Logo
Stockholm University Logo
Swiss Integrative Center for Human Health Logo
The Campaign to Prevent Alzheimer’s Disease Logo
Toulouse University Hospital Logo
Tufts Medical Center
University of California – San Diego Logo
University of California – San Francisco Logo
University of Maryland Logo
University of Michigan Logo
University of North Texas Health Science Center Logo
University of Rhode Island Logo
University of South Hampton Logo
University of Southern California Logo
University of Utah Logo
University of Washington Logo
University of Wisconsin-Madison Logo
Wake Forest University School of Medicine Logo
Washington University Logo
AdventHealth, Oxford Logo
AGREEDementia Logo
Altoida Logo
Alzheimer’s Drug Discovery Fund Logo
ALZPath Logo
Amsterdam UMC Logo
Atrium Health Logo
B.A.B.E.S. Logo
Barrow Neurological Institute Logo
Barcelona Beta Logo