Comparative clinical evaluation of biochemical and genomic tumor markers

The clinical utilities of established biochemical tumor markers and of emerging genomic markers are compared by six formal criteria: [1] tests negative in health or benign disease, [2] produced exclusively by specific tumor cells, [3] present frequently in the targeted malignancy, [4] detectable in occult disease, [5] degree of expression reflects tumor burden and prognosis, and [6] degree of expression correlates with therapeutic result. Evaluation of eight widely accepted marker systems combining a biochemical indicator with a specific cancer, on the one hand, and five representative genomic marker-target combinations involving chromosomal translocation, gene amplification and mutation, on the other hand, produces three main conclusions: First, specified applications are sufficiently well documented for the best biochemical markers to now tailor analytical performance goals to these uses. Second, further clinical trials of genomic markers are needed to document the useful linkage of specific indicators with specific clinical problems. Third, the different profiles of marker characteristics defining the two classes of indicators suggest some mutually complementary uses.