The Global CEO Initiative on Alzheimer’s Disease performance recommendations for blood-based biomarker tests

Published in Nature Reviews Neurology

We are thrilled to announce a major milestone in the diagnosis of Alzheimer's disease with the publication of the first performance recommendations for blood-based biomarker (BBM) tests for Alzheimer’s disease. Crafted by more than 90 leading experts in the field, the CEOi BBM Workgroup standards are now available in Nature Reviews Neurology

Continued advancements related to Alzheimer’s disease-modifying treatments are providing new hope to patients. However, for these tools to reach patients, accurate and timely diagnosis is critical. Blood tests for Alzheimer's could revolutionize Alzheimer's diagnosis since they are more affordable and accessible compared to existing tools.  However, without clear standards, understanding how and where to use BBMs was a major barrier. To address this challenge, CEOi convened stakeholders from healthcare, academia, non-profit, government, industry, and patient advocacy with the goal of preparing for the widespread adoption of BBMs in clinical practice to enable a more simple, timely, and accurate diagnostic experience for patients.

Read the full publication and key takeaways & watch our video with Suzanne Schindler, Workgroup C0-Lead

Key Takeaways from the Publication:

  • Use of BBM tests to confirm disease pathology without further PET or CSF testing, or use as a triaging tool with subsequent confirmatory testing.

  • When used as a confirmatory tool, performance standards should be equivalent to cerebrospinal fluid (CSF) tests, which is 90% sensitivity and specificity.

  • When used in triaging, at least 90% sensitivity, and at least 85% specificity in primary care or 75% in secondary care settings.

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Thank you to everyone who contributed to this monumental piece of work

Suzanne Schindler, Washington University School of Medicine

Oskar Hansson, Lund University; Memory Clinic, Skane University Hospital

Douglas Galasko. University of California, San Diego

Ana Pereira, Icahn School of Medicine, Mount Sinai

Gil Rabinovici, University of California, San Francisco

Stephen Salloway, Brown University

Marc Suarez-Calvet, Barcelonaβeta Brain Research Center

Ara Khachaturian, The Campaign to Prevent Alzheimer's Disease

Michelle Mielke, Wake Forest University School of Medicine

Chi Udeh-Momoh, Wake Forest University School of Medicine

Joan Weiss, Health Resources and Services Administration

Richard Batrla, Eisai

Sasha Bozeat, F. Hoffman–La Roche AG

John Dwyer, Global Alzheimer’s Platform Foundation

Drew Holzapfel, The Global CEO Initiative on Alzheimer's Disease

Daryl Rhys Jones, Eisai

James Murray, Davos Alzheimer’s Collaborative

Katherine Partrick, The Global CEO Initiative on Alzheimer's Disease

Emily Scholler, The Global CEO Initiative on Alzheimer's Disease

George Vradenburg, Davos Alzheimer’s Collaborative; UsAgainstAlzheimer’s

Dylan Young, Guidehouse

Alicia Algeciras-Schimnich, Mayo Clinic, Rochester

Jiri Aubrecht, Prothena Biosciences

Joel Braunstein, C2N Diagnostics

James Hendrix, Eli Lilly and Company

Yan Helen Hu, Eisai

Soeren Mattke, University of Southern California

Mark Monane, C2N Diagnostics

David Reilly, Guidehouse

Elizabeth Somers, Eisai Inc

Charlotte E. Teunissen, Amsterdam University Medical Centers

Eli Shobin, Biogen

Hugo Vanderstichele, Biomarkable BV

Michael Weiner University of California

David Wilson, Quanterix Corporation