Table 1.

Selected Examples of Commercially Available Diagnostic Tests Associated Therapy Implication and Relevant Cancer Type.

Therapy Implications	Test	Cancer Type	Drug-Biomarker Clinical Association
IHC Assays
Cetuximab; Panitumumab	EGFR	CRC	Established
Imatinib	C-KIT	GIST	Established
Trastuzumab	HER2	Breast Cancer; Gastric Cancer	Established
Resistance to PI3K, AKT, and MEK inhibitors	LKB1	NSCLC	Investigational (Mahoney et al., 2009)
Crizotinib	C-MET	NSCLC	Investigational (Sadiq & Salgia, 2013)
Akt/mTOR Inhibitors; resistance to anti- EGFR therapies	PTEN	CRC, NSCLC	Investigational (Di Nicolantonio et al., 2010; Sos et al., 2009; Wang et al., 2012)
In Situ Hybridization Assays
Crizotinib	ALK Fusion FISH	NSCLC	Established
Trastuzumab; Pertuzumab	HER2 FISH	Breast Cancer, Gastric Cancer	Established
Trastuzumab	HER2 CISH	Breast Cancer	Established
Trastuzumab	HER2 ISH	Breast Cancer	Established
Mutation Assays
Cetuximab, Panitumumab	KRAS	CRC, NSCLC, Pancreatic Cancer	Established
Erlotinib, Gefitinib	EGFR	NSCLC, CRC	Established
Vemurafenib, Trametenib, Dabrafenib, Resistance to Anti-EGFR therapies	BRAF	CRC, Thyroid Cancer, Melanoma	Established
Imatinib; 2nd Generation TKIs	BCR-ABL	CML, Ph+ AML	Established
Crizotinib	ALK	NSCLC	Established
RAF and MEK inhibitors, resistance to anti- EGFR therapies,	NRAS	Melanoma, CRC, NSCLC	Investigational (Ascierto et al., 2013; De Mattos-Arruda et al., 2011; De Roock et al., 2010; Huang et al., 2013)
Imatinib	PDGFRA	GIST	Established
PI3K/mTOR Inhibitors	PIK3CA	Breast Cancer, CRC, Lung Cancer	Investigational (Di Nicolantonio et al., 2010; Janku et al., 2013)
Akt/mTOR Inhibitors; resistance to anti- EGFR therapies	PTEN	CRC, NSCLC, Breast	Investigational (Di Nicolantonio et al., 2010; Jerusalem et al.; Sos et al., 2009; Wang et al., 2012)
Resistance to PI3K, AKT, and MEK inhibitors	LKB1	NSCLC	Investigational (Averette-Byers et al., 2012)
Other
Imatinib	BCR-ABL1 Quantitative Transcript Analysis	CML, Ph+ AML	Established
Resistance to Imatinib	BCR-ABL1 Copy Number	CML, Ph+ AML	Investigational (Hochhaus et al., 2002)
PI3K Inhibitors	PIK3CA Amplification	Multiple Cancer Types	Investigational (Rodon et al.)
Erlotinib; Gefitinib; Cetuximab; Panitumumab	EGFR Amplification	NSCLC, CRC	Investigational (Gupta et al., 2009)

The drug-biomarker clinical associations denoted ‘Established’ reflect well known drug FDA indications. The ones denoted ‘Investigational’ are associations that are hypothesized and demonstrated by scientific literature.