Tools for Biomarker Discovery

With the advent of new technologies and targeted therapies (described in the previous sections), there is continued interest in biomarker discovery for clinical development. Recent advances in genomic, proteomic, metabolomic, and imaging technologies continue to provide important tools in biomarker identification.64,79 In addition, the assessment of potential biomarkers using antibody arrays that capitalize on humoral responses to tumor antigens has also garnered interest.88

7.02.9.1 Genomics

Most diseases are complex and the incomplete understanding of their pathogenic mechanisms hampers identification of useful biomarkers. Genomic analysis (SNPs, microarrays) may offer a solution to discover novel biomarkers such as identification of variants in the P450 system which are important in drug metabolism.78,79 There are an estimated 10 million SNPs in the human genome89,90 that could be a potential treasure trove of disease biomarkers. As previously discussed, the expression profiling of tumor types can aid clinical decisions (Oncotype Dx, Genomic Health).85 While these molecular signatures have great potential, the translation of a genotype to distinct phenotypes can be challenging in light of many other confounding factors.91 This is because diseases are multigenic in nature; therefore, multiple SNPs or a panel of biomarkers may prove more correlative to disease status.92,93

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