Evolution of Translational Omics:

HER 2 Early single marker test for guiding cancer therapy Identifies patients likely to benefit from HER2-targeted therapy Currently 7 tests approved by FDA Difficulties remain:• different testing modalities• lab-to-lab variability• false-positive and false-negative results• differences in cut-off recommendations➠ Challenges in implementing a single-analyte test areamplified for a multi-analyte omics-based test.