KRAS and colonic neoplasm: 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.