WHO Preferred product characteristics of blood-based biomarker diagnostics for Alzheimer disease
Diagnosis is the first step into the care journey. To support a timely and accurate dementia diagnosis, it is critical to develop diagnostic tools, such as blood-based biomarker tests, that can support the health-care workforce in their clinical decision-making, and that can be readily implemented in low-resource settings. WHO Preferred Product Characteristics (PPCs) are technical documents that define the preferred attributes of diagnostic products for regulatory purposes, policy, and programmatic implementation. PPCs are intended to encourage innovation and development of products for use in settings more relevant to the global unmet public health need. This PPC defines the preferred parameters of blood-based biomarker diagnostics for Alzheimer disease to ensure that these products will not only exhibit optimal clinical performance but are also relevant to different populations, affordable and available to those who need these products. Considerations for implementation include global access, post-diagnostic support and perspectives of people with lived experience.