Blood-based biomarkers have the potential to revolutionize clinical practice and clinical trials in Alzheimer disease (AD). However, to date, this “holy grail” opportunity has not been realized owing to a broad range of issues, including the lack of a clearly defined context of use (COU), lack of standardization of methods, and numerous failures at replication. Recently, however, a shift in the paradigm has occurred, with my colleagues and I proposing specific COUs for blood-based biomarkers along with potential paradigms for advancing from discovery to clinic and potential acceptable standards.1,2
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