The Global CEO Initiative on Alzheimer’s Disease Comment on the World Health Organization’s Preferred Product Characteristics for Blood Tests for Alzheimer’s Disease
The World Health Organization (WHO) put out a call for public consultation on their preferred product characteristics (PPC) blood-based biomarker diagnostics for Alzheimer’s disease. WHO Preferred Product Characteristics (PPCs) are technical documents that define the preferred attributes of diagnostic products for regulatory purposes, policy, and programmatic implementation.
The Global CEO Initiative on Alzheimer’s Disease (CEOi) is pleased to submit a public comment letter on the World Health Organization’s (WHO) draft preferred product characteristics (PPC) for Alzheimer’s disease (AD) blood-based biomarkers (BBM).
CEOi was founded to connect the patient advocacy organization UsAgainstAlzheimer’s with multisector organizations interested in addressing Alzheimer’s. With more than a decade of experience in the Alzheimer’s field, CEOi brings together the public and private sectors, non-profit community, and academia to catalyze, convene, align and strengthen efforts to treat and prevent Alzheimer’s.
In line with our mission to drive scientific innovation into routine clinical care, CEOi convened a BBM Workgroup in January 2023. Comprised of more than 90 leading Alzheimer’s experts, the Workgroup aimed to prepare relevant stakeholders, such as practicing clinicians and health systems, for the widespread adoption of BBMs in the US and beyond. The objectives included (1) defining use cases and ideal performance standards to empower healthcare professionals with clear guidelines on selecting the most appropriate tests, and (2) providing actionable recommendations for healthcare professionals to understand where BBMs fit in the patient pathway and clinical workflows. With diverse participants from academia, non-profits, government, venture capital, industry, and advocacy, the BBM Workgroup addressed crucial questions and found consensus on complex issues regarding access and adoption to BBMs. These recommendations are expected to be published in high-impact peer reviewed journals this year.
We emphasize the urgent need for expert consensus and multistakeholder collaboration around how to effectively utilize and implement high performing AD BBM tests in real-world settings. CEOi recognizes and applauds WHO’s PPCs for AD BBM tests, acknowledging a valuable synergy between both sets of recommendations and particularly appreciating WHO’s PPCs global perspective. We support these recommendations as a pivotal step toward harnessing the full potential of this diagnostic tool and advancing Alzheimer’s care and diagnostics.
Read CEOi’s feedback here.