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BIOSPECIMENS: The Source of Biomarkers. Carolyn Compton, MD, PhD National Biomarkers Development Alliance Public Forum Arizona State University March 25, 2013. NBDA BIOSPECIMENS. Biomarkers. Molecular Data. PERSONALIZED/PRECISION MEDICINE. Biospecimen Analysis.
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BIOSPECIMENS: The Source of Biomarkers Carolyn Compton, MD, PhD National Biomarkers Development Alliance Public Forum Arizona State University March 25, 2013
NBDA BIOSPECIMENS Biomarkers Molecular Data PERSONALIZED/PRECISION MEDICINE Biospecimen Analysis Biospecimen Processing, Banking, Data Capture Biospecimen Collection Biospecimen processing and banking DETERMINES QUALITY HERE QUALITY HERE
IMPACT OF POOR QUALTY BIOSPECIMENSON BIOMARKERS • Irreproducible research results • Variations in gene expression data • Variations in post-translational modification data • Misinterpretation of artifacts as biomarkers • Potential for incorrect diagnosis • Morphological/immunostaining artifact • Skewed clinical chemistry results • Potential for incorrect treatment • Therapy linked to a diagnostic test on a biospecimen (e.g., HER2 in breast cancer)
NDBA BIOSPECIMENS AND BIOBANK • Poor quality biospecimens + High quality biorepository • High quality biospecimens+ Low quality biorepository • High quality biospecimens+High quality biorepository NDBA • The right samples from the right patients at the right time • Evidence-based collection, processing, storage protocols • Quality verification at every step, every time • Rich, diverse data on every sample • Best specimen type for the intended assay • “Fit for purpose” • Purpose defined by analysis method for the target biomolecule type and the intended use of the analysis data