Table 4.

Indication and associated CDxs

FDA-Approved indication	FDA-approved companion diagnostic
Breast cancer	BRACAnalysis CDx FoundationOne CDx INFORM HER-2/neu PathVysion HER-2 DNA Probe Kit PATHWAY anti-Her2/neu (4B5) Rabbit Monoclonal Primary Antibody InSite Her-2/neu KIT SPOT-LIGHT HER2 CISH Kit Bond Oracle HER2 IHC System HER2 CISH pharmDx Kit INFORM HER2 Dual ISH DNA Probe Cocktail HercepTest HER2 FISH pharmDx Kit Therascreen PIK3CA RGQ PCR Kit VENTANA HER2 Dual ISH DNA Probe Cocktail FoundationOne ® Liquid CDx Ki-67 IHC MIB-1 pharmDx (Dako Omnis)
Non-small cell lung cancer (NSCLC)	Therascreen EGFR RGQ PCR Kit Cobas EGFR Mutation Test v2 PD-L1 IHC 22C3 pharmDx FoundationOne CDx VENTANA ALK (D5F3) CDx Assay Oncomine Dx Target Test Therascreen KRAS RGQ PCR Kit Vysis ALK Break Apart FISH Probe Kit PD-L1 IHC 28–8 pharmDx Guardant360® CDx FoundationOne ® Liquid CDx Onco/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA) Ventana PD-L1 (SP263) Assay
Colorectal Cancer	FoundationOne CDx Praxis Extended RAS Panel Cobas KRAS Mutation Test Therascreen KRAS RGQ PCR Kit Dako EGFR pharmDx Kit Therascreen BRAF V600E RGQ PCR Kit Onco/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA)
Ovarian cancer	BRACAnalysis CDx FoundationOne CDx FoundationFocus CDxBRCA Assay Myriad myChoice CDx FoundationOne ® Liquid CDx
Metastatic castrate resistant prostate cancer (mCRPC)	BRACAnalysis CDx FoundationOne CDx FoundationOne ® Liquid CDx
Gastric or gastroesophageal junction adenocarcinoma	PD-L1 IHC 22C3 pharmDx HercepTest HER2 FISH pharmDx Kit
Urothelial carcinoma	PD-L1 IHC 22C3 pharmDx Therascreen FGFR RGQ RT-PCR Kit Ventana PD-L1 (SP142) Assay
Acute myeloid leukemia	Abbott RealTime IDH1 Abbott RealTime IDH2 LeukoStrat CDx FLT3 Mutation Assay
Melanoma	THXID BRAF Kit Cobas 4800 BRAF V600 Mutation Test FoundationOne CDx