The Global CEO Initiative on Alzheimer’s Disease Publishes the First Performance Recommendations for Blood-Based Biomarker Tests by Experts in the Field

Diverse group of stakeholders address key barrier to implementing BBM’s through publishing consensus performance recommendations

/EIN News/ -- Philadelphia, Pennsylvania, June 12, 2024 (GLOBE NEWSWIRE) -- The Global CEO Initiative on Alzheimer’s Disease (CEOi), convened by UsAgainstAlzheimer’s, is proud to announce the peer-reviewed publication of their latest manuscript by their Blood-Based Biomarker (BBM) Workgroup, “The Global CEO Initiative on Alzheimer’s Disease performance recommendations for blood-based biomarker tests” in the journal Nature Reviews Neurology. 

“Blood tests for Alzheimer’s disease promise to provide an earlier and more accurate diagnosis for many patients with cognitive impairment.  However, some currently available blood tests are extremely accurate while others are little better than flipping a coin.  We worked with many different stakeholders to develop minimum standards for the accuracy of these blood tests, because we know that a timely and accurate diagnosis of Alzheimer’s disease has a major impact on a patient’s life,” said Dr. Suzanne Schindler, Department of Neurology, Washington University School of Medicine and BBM Workgroup Co-Lead.  

The widespread adoption of amyloid positron emission tomography (PET) and cerebrospinal fluid (CSF) biomarkers has been hindered by cost, accessibility barriers in clinical care settings, and a lack of general guidelines for evaluation. However, as advancements in disease-modifying treatments for early symptomatic Alzheimer’s disease continue to emerge, there is an urgent need for earlier and more accessible diagnostic methods, including biomarker testing. 

CEOi convened a BBM Workgroup of 90 stakeholders from healthcare, academia, non-profit, government, venture capital, industry, and patient advocacy to establish minimum acceptable performance standards for BBM tests in clinical practice. These standards reflect an expert consensus, marking the first-time stakeholders have united to establish a common framework. 

“Expert consensus on the performance and use of new diagnostic tools was critical to spur transforming care for conditions like cancer and heart disease. With the publication of these recommendations, we are excited that patients and their families will have more timely and equitable access to new, innovative Alzheimer’s therapeutics,” said George Vradenburg, convener of CEOi.   

The performance standards published today outline how BBM tests can be used either as confirming the presence of disease pathology without further amyloid PET or CSF testing or as a triaging test where follow-up imaging or CSF is needed.  For confirmation of pathology, the workgroup recommends BBM tests show performance equivalent to CSF tests for confirmation. While for the triaging process the workgroup recommends >85 specificity in primary care and > 75 in secondary care depending upon availability of follow-up testing. 

By adhering to these performance standards, high-quality BBM tests have the potential to revolutionize Alzheimer's diagnosis, enabling more patients to receive the timely and accurate assessment of whether they may wish to consider using newly approved disease-modifying treatments. 

For more information, please visit the CEOi BBM website.

About CEOi: The Global CEO Initiative on Alzheimer’s Disease (CEOi), convened by UsAgainstAlzheimer’s in 2013, is an organization of global private-sector leaders from across the pharmaceutical, biotech, diagnostics, caregiving and financial sectors, who have joined together to provide business leadership in the fight against Alzheimer’s. CEOi partners with leaders from all sectors to transform the disease from a social, health, and economic crisis into an opportunity for healthy aging worldwide. 

Media requests should be directed to: Caroline Hubbard, CEOi Secretariat chubbard@highlanterngroup.com. 

Caroline Hubbard
                    The Global CEO Initiative on Alzheimer's Disease
                    415-860-6565
                    chubbard@highlanterngroup.com