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Bias and poor biospecimen design
Creation of bias by protocol variation across clinical sample sets
Creation of bias by use of tissue and body fluid study sets that are not representative of the clinical problem
Generation of false-positives and false-negatives by tissue heterogeneity, improper sample handling and tracking, inadequate or improper fixation and storage
Failure of blinded clinical validation
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Uniform protocols for collection of tissues and body fluids Preservation technologies for tissue and body fluid sample collection Use of tissue study sets that represent the clinical problem Microdissection of tissue cell subpopulations to generate accurate and precise concentrations of the biomarker and cutpoints for clinical implementation Inclusion of independent epidemiologically credentialed and matched cohorts with benign tumors, inflammatory disease, and hormonal differences during discovery and verification phases
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Correlation without causality
Failure to functionally link a blood biomarker to the tumor itself
Failure to functionally link a tissue biomarker with the biochemical process or mechanism of action of a drug
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Validation of the same biomarker across a series of experimental animal tumor models and human xenografts Mechanistically associating the biomarker to tumorigenesis Linking the biomarker with the mechanism of action of a drug Showing a change in the biomarker after successful therapy or recurrence
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Nanotechnology-based methods for biomarker capture, preservation, and exclusion of unwanted high-abundance proteins such as albumin can amplify mass spectrometry sensitivity 1,000-fold Development of new multiplexed assay technologies that have analytic abilities to Quantitatively measure hundreds of analytes at once from tiny input specimens
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