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] tes ts negative in health or benign disease, [2] produced exclusively- by specific tumor cells, [3] present frequently in the targeted malignanc y, [4] detectable in occult disease, [5] degree of expression reflects tumor burden and prognosis, and [6] degree of expression correlates w ith therapeutic result. Evaluation of eight widely accepted marker sys tems combining a biochemical indicator with a specific cancer, on the one hand, and five representative genomic marker-target combinations i nvolving chromosomal translocation, gene amplification and mutation, o n the other hand, produces three main conclusions: First, specified ap plications are sufficiently well documented for the best biochemical m arkers to now tailor analytical performance goals to these uses. Secon d, further clinical trials of genomic markers are needed to document t he useful linkage of specific indicators with specific clinical proble ms. Third, the different profiles of marker characteristics defining t he two classes of indicators suggest some mutually complementary uses.