The promise of molecular diagnostics for cancer prevention in terms of early detection rests on two premises: assays can be developed to measure proteins, DNA, RNA or metabolites that accurately and reproducibly detect incipient neoplasias; and that this early detection will eventually result in a decrease in morbidity and mortality and therefore benefit patients. Novel molecular technologies, including laser capture microdissection, time-of-flight mass spectrometry, DNA microarrays, tissue arrays, protein microarrays and antibody microarrays, are being developed to investigate the molecular differences between disease and normal cells and detect cancer-specific alterations in proteins, DNA and RNA in body fluids. Although literally hundreds of articles are published each year describing alterations in genes or proteins that are associated with cancer, very few result in useful molecular diagnostics for early cancer detection. Thus, there remains a critical need for new biomarkers for use in early detection and for assay methods that allow the translation of these biomarkers from the laboratory to the clinic.
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