New molecular assays for cancer diagnosis and targeted therapy.

Microarray multiplex protein measurement of biomarker-based molecular diagnostic and prognostic cancer testing assays is destined to become a large growth segment of the immunodiagnostic industry. Assays encompass immunohistochemistry, fluorescence in situ hybridization, ELISA and sequencing methods that must comply with stringent regulatory specifications. Current test services available range from single-site service-based assays to multi-laboratory testing. Some tests have regulatory approval, whereas others are regulated by the Clinical Laboratory Improvement Act or the College of American Pathologists, or both. Expectations of personalized medicine are building, and the future is expected to bring truly targeted treatments based on test results. In this review, biomarkers, screening, diagnosis, potential prognosis and treatment pertaining to colorectal, breast, and lung cancers are discussed and evaluated. Assay data are expected to improve clinical indices and treatment algorithms, leading to dynamic disease models for real-time, data-modulated patient management.