Two of the devices, FoundationOne CDx and ONCO/Reveal Diagnostic Lung and Colon Cancer Assay, already include therapeutic class labeling for other indications, and a third device, Cobas KRAS Mutation Test, is manufactured by Roche Molecular Systems, Inc., which has therapeutic class labeling for its other device, Cobas EGFR Mutation Test v2. This evidence concerns the gene EGFR and malignant colon neoplasm.