Academic medical centers as innovation ecosystems to address population –omics challenges in precision medicine

Silva, Patrick J.; Schaibley, Valerie M.; Ramos, Kenneth S.

doi:10.1186/s12967-018-1401-2

Journal of Translational Medicine

Table 1 Comprehensive table of FDA approved companion diagnostics and their corresponding drug.

From: Academic medical centers as innovation ecosystems to address population –omics challenges in precision medicine

Biomarker (only FDA approved assays are listed)	Tumor type	Therapies guided	NDA	PMA	Analytic method
CD117
D816V	Aggressive systemic mastocytosis	Imatinib	NDA21335	H140006	PCR
Protein		Imatinib	NDA21335, NDA021588	P040011/S001/S002	IHC
PDGF receptor B
Rearrangment		Imatinib	NDA21335	H140005	FISH
EGFR receptor
Exon 19 deletions,T790M	Non-small cell lung	Osimertinib	NDA208065	P120019, S007	PCR
Exon 19 deletions, L858R	Non-small cell lung	Gefitinib, afatinib	NDA206995, NDA201292	P120022/S001	PCR
EGFR receptor protein	Non-small cell lung	Cetuximab, panitumumab	BLA125084, BLA125147	P030044/S001/S002	IHC
Exon 19 deletions, L858R	Non-small cell lung	Erlotinib	NDA021743	P120019/S001/S004	PCR
Exon 19 deletions, L858R	Non-small cell lung	Afatinib	NDA201292	P120022/S001	PCR
Exon 19 deletions, T790 M	Non-small cell lung (circulating tumor)	Erlotinib, osimertinib	NDA208065, NDA021743	P150044, P150047	RTPCR
Exon 19 deletions, L858R	Non-small cell lung	Gefitinib	NDA206955	P170021	NGS
Exon 19 deletions, T790M	Non-small cell lung	Osimertinib	NDA208065	P170021	NGS
Exon 19 deletions, L858R	Non-small cell lung	Erlotinib	NDA021743	P170021	NGS
Exon 19 deletions, L858R	Non-small cell lung	Afatinib	NDA201292	P170021	NGS
Exon 19 deletions, L858R	Non-small cell lung	Gefitinib	206995	P160045	NGS
Her2/Neu
Gene amplification	Breast cancer	Trastuzumab	BLA103792	P940004	FISH
Gene amplification	Breast cancer	Trastuzumab	BLA103792	P980024/S001/S012	FISH
Gene amplification	Breast cancer	Trastuzumab	BLA103792	P050040/S001/S003	CISH
Gene amplification	Breast cancer, gastric/gastro-esophogeal tumor	Trastuzumab, adotrastuzumab emtansine, pertuzumab	BLA103792, BLA125409	P040005	FISH
Gene amplification: Chrom 17	Breast cancer	Trastuzumab	BLA103792	P100024/S001/S005	CISH
Protein	Breast cancer	Trastuzumab	BLA103792	P090015	IHC
Protein	Breast cancer	Trastuzumab	BLA103792	P990081/S001/S028	IHC
Protein	Breast cancer	Trastuzumab	BLA103792	P040030	IHC
Protein	Breast cancer	Trastuzumab	BLA103792	P980018/S001/S002	IHC
Protein	Breast cancer, gastric/gastroesophogeal Tumor	Trastuzumab, adotrastuzumab-emtansine, pertuzumab	BLA103792, BLA125409	P980018/S001/S002	IHC
Gene amplification	Breast cancer	Trastuzumab	BLA103792	P170021	NGS
Gene amplification	Breast cancer	Pertuzumab	BLA125409	P170021	NGS
Gene amplification	Breast cancer	Adotrastuzumab emtansine	BLA125427	P170021	NGS
KRAS
Codon 12 and 13 mutations	Colorectal cancer	Cetuximab, panitumumab	BLA125084, BLA125147	P110030, P110027	PCR
	Colorectal cancer	Cetuximab, panitumumab	BLA125084, BLA125147	P140023	PCR
KRAS wild-type (absence of mutations in codons 12 and 13)	Colorectal cancer	Cetuximab	BLA125084	P170021	NGS
RAS wild-type (absence of mutations in exons 2, 3, and 4) and NRAS wild type (absence of mutations in exons 2, 3, and 4)	Colorectal cancer	Panitumumab	BLA125147	P170021	NGS
56 specific mutations in RAS genes [KRAS (exons 2, 3, and 4) and NRAS (exons 2, 3, and 4)]	Colorectal cancer	Panitumumab	BLA125147	P160038	NGS
BRCA1 and BRCA 2
Deleterious alterations	Breast cancer	Olaparib	NDA206162	P140020	PCR- > Sanger sequencing
Deleterious alterations	Ovarian cancer	Rucaparib	NDA209115	P160018	NGS
Deleterious alterations	Breast and ovarian cancer	Olaparib	NDA208558	P140020/S012	PCR- > Sanger sequencing
Deleterious alterations	Breast cancer	Rucaparib	NDA209115	P170021	NGS
Deleterious alterations	Breast cancer	Rucaparib	NDA209115	P160018	NGS
Deleterious alterations	Breast cancer	Cobimetinib + vemurafenib	NDA206192	P170021	NGS
PD-1
Protein	NonSmall Cell Lung	Pembrolizumab	BLA125514/S5	P150013	IHC
Protein	NonSmall cell lung cancer, gastric and gastroesophageal junction adenocarcinoma	Pembrolizumab	sBLA125514/s24	P150013/S006	IHC
Protein	NonSmall Cell Lung	Pembrolizumab	BLA125514 (S008 and S012)	P150013/S001	IHC
ALK
Protein	NonSmall Cell Lung	Crizotinib	NDA202570	P140025	IHC
Rearrangement	NonSmall Cell Lung	Crizotinib	NDA202570	P110012	FISH
Rearrangement	NonSmall Cell Lung	Crizotinib	NDA202570; NDA 202570/S-021	P170021	NGS
Rearrangement	NonSmall Cell Lung	Alectinib	NDA208434/S-003	P170021	NGS
Rearrangement	NonSmall Cell Lung	Ceritinib	NDA 205755/S-009	P170021	NGS
Protein	NonSmall Cell Lung	Ceritinib	sDNA 205755-09 (NDA supplement)	P140025/S005	IHC
BRAF
V600E/K	Melanoma	Tramatenib, dabrafenib	NDA204114, NDA202806	P120014	PCR
V600E	Melanoma	Vemurafenib	NDA202429	P110020	PCR
V600E/K	Melanoma	Vemurafenib	NDA202429	P170021	NGS
V600E	Melanoma	Dabrafenib	NDA202806; NDA 202806/S-006	P170021	NGS
V600E	Melanoma	Trametinib	NDA 204114; NDA 204114/S-005	P170021	NGS
V600E	Melanoma	Trametinib	NDA 204114; NDA 204114/S-006	P160045	NGS
V600E	Melanoma	Dabrafenib	NDA202806/S006	P160045	NGS
17p−	B cell chronic lymphocytic leukemia	Venetoclax	NDA208573	P150041	FISH
ROS
ROS1 fusion	NonSmall Cell Lung	Crizotinib	NDA 202570; NDA 202570/S-021	P160045	NGS (RNA)
Isocitrate dehydrogenase-2
IDH2 mutations (R140Q, R140L, R140G, R140W, R172K, R172M, R172G, R172S, and R172W)	Acute myeloid leukemia	Enasidenib	NDA209606	P170005	PCR
FLT3
FLT3 D835 and I836 mutation	Acute myeloid leukemia	Midostaurin	NDA207997	P160040	PCR

IHC immunohistochemistry, FISH florescent in situ hybridization, RTPCR reverse transcriptase polymerase chain reaction, T790M threonine to methionine mutation at amino acid position 790 in human epidermal growth factor receptor, D816V aspartic acid to valine mutation at amino acid position 816 in human epidermal growth factor receptor

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ISSN: 1479-5876

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