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 escholler@highlanterngroup.com
