Biology Reference
In-Depth Information
CHAPTER
28
Analytical Methods and Biomarker
Validation
Haleem J. Issaq, Timothy D. Veenstra
Laboratory of Proteomics and Analytical Technologies, Advanced Technology Program, Frederick
National Laboratory, Frederick, MD, USA
OUTLINE
Introduction
447
Phase 2: Clinical assay development for
clinical disease
449
Discussion
448
Phase 3: Retrospective longitudinal repository
studies
Analytical Method Validation
448
449
Experimental Design and Execution
448
Phase 4: Prospective screening studies
450
Phase 5: Cancer control studies
450
Biomarker Identi
cation and Con
rmation 449
Conclusions
450
Biomarker Validation
449
Phase 1: Preclinical exploratory studies to
identify potentially useful markers
References
450
449
INTRODUCTION
candidate biomarker. Validation also applies to
the experimental steps leading to the biomarker
'
s
discovery, including study design, experimental
setup, data acquisition, data processing, and inter-
pretation of the results. Analytical validation
involves instrument quali
Graduating a discovered potential biomarker
from the laboratory to the clinic requires careful
con
rmationandvalidation. Validationof a candi-
date protein ormetabolite biomarker involves
ve
major steps, as discussed later in this chapter.
However, clinical evaluation of a biomarker does
not mean that validation applies only to the
cation and method
validation. Instrument quali
es that
the selected instrument is suitable for its intended
use, has been quali
cation veri
ed by the manufacturer, and
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