Alzheimers disease biomarkers: from concept to clinical utility
Faculty of Pharmaceutical, Biomedical and Veterinary Sciences . Biomedical Sciences
New York, N.Y. :Nova Science Publishers, 2008
Biomarkers for early diagnosis of Alzheimers disease / Galimberti, Daniela [edit.]; et al. [edit.]
University of Antwerp
The development of validated biomarkers for Alzheimers disease is essential toimprove diagnosis and accelerate the development of new therapies. This chapterprovides a roadmap for AD biomarker development, illustrating the optimization, qualification, and clinical validation of a potential assay through the example of a new multiplex biomarker test (INNO-BIA AlzBio3) that quantifies key AD biomarkers in cerebrospinal fluid. Both the product and analytical qualification of this assay are presented in detail, followed by the clinical qualification of the test using autopsyconfirmed samples from demented patients. Finally, the analytical performance of the test in a multicenter study carried out in the United States and Europe is discussed. It is clear that the process of biomarker development in general, and for Alzheimers disease biomarkers in particular, is fraught with particular challenges that must be addressed in order to bring potential AD biomarkers to clinical utility.