23 October 2024
The World Health Organization (WHO) has published the Preferred Product Characteristics (PPC) for blood-based biomarker diagnostics for Alzheimer’s disease (AD), aiming to guide the development of accessible, accurate tests that could be used globally, including in low- and middle-income countries (LMICs). This PPC targets funders, researchers, and developers seeking WHO recommendations and offers crucial guidelines to enhance AD diagnostics’ clinical performance. Blood-based biomarkers show potential for earlier, accurate AD diagnosis, especially valuable in settings with limited access to advanced imaging or cerebrospinal fluid (CSF) analysis.
The PPC outlines essential diagnostic standards, including accessibility, affordability, and adaptability to diverse populations and clinical contexts. Emphasizing the need for real-world applicability, especially in LMICs, it also stresses post-diagnostic support and the involvement of those with lived experience of dementia in the test development process. Developed with input from global experts and public consultation, the PPC aims to make AD diagnostics more equitable, ultimately enabling more timely access to support and care for those affected.
