Table 1. Select cancer biomarkers, targeted therapies, and clinical assay availability.

Biomarker	Targeted therapy	Tumor	Clinical assay(s) available	Molecular profiling methodology
ALK/ROS1	Crizotinib, ceritinib	Lung	Vysis ALK Break Apart FISH probe kita	FISH
BRAF (V600E)	Vemurafenib, dabrafenib, trametinib	Lung, melanoma	Cobas 4800 BRAF V600E Mutation Testa; THxID BRAF testa	Real time PCR
C-KIT	Imatinib mesylate	Lung, GIST	C-KIT pharmDxa	IHC
EGFR	Erlotinib, afatinib	Lung, colorectal	EGFR pharmDxa, Therascreen EGFR RGQ PCR kita; Cobas EGFR Mutation Testa	IHC, Sanger Sequencing, PCR
HER2 (ERBB2)	Trastuzumab, lapatinib, pertuzumab, ado-trastuzumab-emtansine, dacomitinib	Lung, breast	HercepTesta, Pathwaya, Insitea, PathVysiona, SPOT-Lighta, HER2 CISHa	IHC, FISH, CISH
JAK2	Ruxolitinib	Lung, myelofibrosis and other myeloproliferative disorders	JAK2 V617F Mutation Detection Assay, HTScan JAK2 Kinase Assay Kit	Real time PCR, Kinase activity assay
PD-1	Pembrolizumab, nivolumab	Lung, melanoma	In development	N/A
KRAS	Cetuximab, panitumumab	Lung, colorectal	Therascreen KRAS RGQ PCR Kita, DxS KRAS Mutation Test Kit, Genzyme’s KRAS Mutation Analysis	Real time PCR

^a, assays that are FDA approved, PMA or 510(k) status. IHC, immunohistochemistry; HER2, human epidermal growth factor receptor-2; CISH, chromogenic in situ hybridization; FISH, fluorescence in situ hybridization; PCR, polymerase chain reaction; EGFR, epithelial growth factor receptor; GIST, gastrointestinal stromal tumor; ALK, anaplastic lymphoma kinase; JAK2, janus kinase 2; PD-1, programmed cell death 1; ROS1, ROS proto-oncogene 1, receptor tyrosine kinase.