Affiliations: [a] Tetracore, Inc., Gaithersburg, MD 20878, USA | [b] Biotechnology Division Chemical Science and Technology Laboratory, National Institute of Standards and Technology, Gaithersburg, MD 20899, USA | NIST Division of Biochemical Sciences, Chemical Sciences and Technology Laboratory, National Institute of Standards and Technology, Gaithersburg, MD, USA
Correspondence:
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Corresponding author: NIST, Biotechnology Division, 100 Bureau Drive, MS 8311, Gaithersburg, MD 20899, USA. Tel.: +1 301 975 4098; Fax: +1 301 975 8505; E-mail: [email protected].
Abstract: As large scale genomics and proteomics efforts identify an increasingly complex list of biomarkers to identify human disease, populations predictive for that disease, and drug or other therapy responses for treatment, attention is needed in the research and development arena to bring initial discoveries to clinical utility. This article reviews the process of biomarker test verification and analytical validation, utilizing measurement standardization. Two such measurement programs are described in this manuscript: the identification of mutations in human mitochondrial DNA, and the measurement of telomerase activity in cancer. These model programs address the need for a standardized procedure outlining critical steps to assessing whether a biomarker assay should proceed to clinical validation, and to identify whether reference materials development is needed to establish measurement accuracy and sensitivity.
