Molecular Profiling Testing Menu | Caris Life Sciences

Comprehensive Tumor Profiling

Caris molecular profiling utilizes a comprehensive approach to assess DNA, RNA and proteins to reveal a molecular blueprint to guide more precise and individualized treatment decisions from among 75+ FDA-approved therapies.

Tumor Profiling Options

The information below details the biomarkers analyzed by technology for the tumor type submitted. Tests may vary if insufficient tumor samples are submitted.

MI Profile Comprehensive Testing

MI Tumor Seek Hybrid^{^TM} (NGS-based WES and WTS) plus Immunohistochemistry and Other Tests by Tumor Type. Caris FOLFIRSTai^{^TM} reported for mCRC cases.

Next-Generation Sequencing Only

MI Tumor Seek Hybrid^{^TM}, including NGS-based whole exome sequencing and whole transcriptome sequencing. Caris FOLFIRSTai™ reported for mCRC cases.

Next-Generation Sequencing (all tumor types)

Whole Exome Sequencing
Alterations	SNVs, Indels, CNAs, Karyotyping, Viruses
Genomic Signatures/Other	gLOH, MSI, TMB, HLA Genotyping, Homologous Recombination Deficiency (HRD)

Whole Transcriptome Sequencing
Alterations	Fusions, Variant Transcripts, Gene Expression*

AI-Powered Molecular Signatures

Caris GPSai^™*
Cancer type similarity assessment that is intended to help identify the tumor of origin by comparing the molecular characteristics of the patient's tumor against other tumors in the Caris database.

Caris FOLFIRSTai^™*
Chemotherapy response predictor that is intended to gauge a mCRC patient's likelihood of benefit from first-line FOLFOX+BV followed by FOLFIRI+BV, versus FOLFIRI+BV followed by FOLFOX+BV treatment.

Tumor Type:

Select tumor type to see specific tests to be performed

Tumor Type	Immunohistochemistry (IHC)	Other
Bladder	MMR, PD-L1 (SP142, 22c3)
Breast	AR, ER, Her2/Neu, Ki-67^, PD-L1 (22c3), PR, PTEN
Cancer of Unknown Primary – Female	AR, ER, Her2/Neu, MMR, PD-L1 (SP142)
Cancer of Unknown Primary – Male	AR, HER2/Neu, MMR, PD-L1 (SP142)
Cervical	ER, MMR, PD-L1 (22c3), PR
Cholangiocarcinoma/ Hepatobiliary	Her2/Neu, MMR, PD-L1 (SP142)	Her2 (Chromogenic in situ Hybridization)
Colorectal and Small Intestinal	Her2/Neu, MMR, PD-L1 (SP142), PTEN
Endometrial	ER, MMR, PD-L1 (SP142), PR, PTEN
Esophageal Cancer	Her2/Neu, MMR, PD-L1 (22c3)
Gastric/GEJ	Her2/Neu, MMR, PD-L1 (22c3)	EBER, Her2 (Chromogenic in situ Hybridization)
GIST	MMR, PD-L1 (SP142), PTEN
Glioma	PD-L1 (SP142)	MGMT Methylation (Pyrosequencing)
Head & Neck	MMR, p16, PD-L1 (22c3)	EBER, HPV (Chromogenic in situ Hybridization), HPV reflex to confirm p16 result
Kidney	MMR, PD-L1 (SP142)
Lymphoma/Leukemia
Melanoma	MMR, PD-L1 (SP142)
Merkel Cell	MMR, PD-L1 (SP142)
Neuroendocrine	MMR, PD-L1 (SP142)
Non-Small Cell Lung	ALK^†, PD-L1 (22c3, 28-8, SP142, SP263)
Ovarian	ER, FOLR1^#, MMR, PD-L1 (22c3), PR
Pancreatic	MMR, PD-L1 (SP142)
Prostate	AR, MMR, PD-L1 (SP142)
Salivary Gland	AR, Her2/Neu, MMR, PD-L1 (SP142)
Sarcoma	MMR, PD-L1 (SP142)
Small Cell Lung	PD-L1 (22c3)
Thyroid	MMR, PD-L1 (SP142)
Uterine Serous	ER, Her2/Neu, MMR, PD-L1 (SP142), PR, PTEN	Her2 (Chromogenic in situ Hybridization)
Vulvar Cancer (SCC)	MMR, PD-L1 (22c3)
Other Tumors	MMR, PD-L1 (SP142)
MMR = Mismatch Repair proteins: MLH1, MSH2, MSH6, PMS2 ^†ALK IHC only performed for NSCLC adenocarcinoma. #FOLR1 IHC and HRD Status only performed for epithelial ovarian cancer. ^Ki-67 IHC only for early stage breast cancer. * Not available in all locations.

Order Profiling

Place an order today for a comprehensive, personalized Caris profiling report.

Caris applies the appropriate tumor-specific customizations standard with every order.
In certain instances, some biomarkers or genes ordered individually will not associate with commercially available cancer therapies or clinical trials.
For PD-L1 IHC testing, Dako antibodies 22c3, 28-8 and antibodies SP-142 and SP263 are used as appropriate.
For certain patients, HER2 testing is performed by Chromogenic in situ Hybridization, in addition to Next-Generation Sequencing.

Reflex Testing Menu

Comprehensive molecular profiling from Caris Life Sciences® assesses DNA, RNA, and proteins with multiple technologies including next-generation sequencing

Sufficient tumor content (>20% tumor nuclei) must be present to complete all analyses. If you have any questions, please contact Customer Support at (888) 979-8669.

Technical Information	IHC	CISH
Sample Requirements (see requisition for full details)	1 unstained slide at 4μm thickness from FFPE block, with evaluable tumor present, per IHC test	1 unstained slide at 4μm thickness from FFPE block, with at least 100 evaluable tumor cells present, per CISH test
Sensitivity/Specificity	>95%	>95%

Technical Information	NGS (Whole Exome – DNA)	NGS (Whole Transcriptome – RNA)
Sample Requirements	FFPE block or 10 unstained slides with a minimum of 20% malignant origin for DNA and 10% malignant origin for RNA. Needle biopsy is also acceptable (4-6 cores).
Tumor Enrichment (when necessary)	Microdissection to isolate and increase the number of cancer cells to improve test performance and increase the chance for successful testing from small tumor samples
Number of Genes	23,000+ genes	23,000+ genes
Average Depth of Coverage (DNA) Average Read Count (RNA)	800x for clinical genes	23 million reads
Positive Percent Agreement (PPA)	>95% for base substitutions at ≥ 5% mutant allele frequency; >95% for indels at ≥ 5% mutant allele frequency; >90% for copy number alterations (amplifications ≥ 6 copies)	>97%
Negative Percent Agreement (NPA)	>99%	>99%
Viruses*	HPV 16 & 18 (Head & Neck, Anal, Genital, CUP)
Genomic Signatures/Other	Genomic Loss of Heterozygosity (gLOH) Homologous Recombination Deficiency (HRD)* Microsatellite Instability (MSI) Tumor Mutational Burden (TMB) Human Leukocyte Antigen (HLA) Genotype*
* Not available in all locations.

ABL	ABL1	ACVR1	AIP	AKT1	AKT2	AKT3	ALK	AMER1	APC
AR	ARAF	ARHGAP26	ARHGAP35	ARID1A	ARID2	AR-V7	ASXL1	ATM	ATR
ATRX	AXIN1	AXIN2	AXL	B2M	BAP1	BARD1	BCL2	BCL9	BCOR
BCR	BLM	BMPR1A	BRAF	BRCA1	BRCA2	BRD3	BRD4	BRIP1	BTK
CALR	CARD11	CASP8	CBFB	CCND1	CCND2	CCND3	CD79B	CDC73	CDH1
CDK12	CDK4	CDK6	CDKN1B	CDKN2A	CHEK1	CHEK2	CIC	CREBBP	CSF1R
CTCF	CTNNA1	CTNNB1	CXCR4	CYLD	CYP17A1	DDR2	DICER1	DNMT3A	EGFR
EGFR vIII	EGLN1	ELF3	EP300	EPHA2	ERBB2	ERBB3	ERBB4	ERCC2	ERG
ESR1	ETV1	ETV4	ETV5	ETV6	EWSR1	EXO1	EZH2	FANCA	FANCB
FANCC	FANCD2	FANCE	FANCF	FANCG	FANCI	FANCL	FANCM	FAS	FAT1
FBXW7	FGFR1	FGFR2	FGFR3	FGFR4	FGR	FH	FLCN	FLT1	FLT3
FLT4	FOXA1	FOXL2	FUBP1	FYN	GALNT12	GATA3	GLI2	GNA11	GNA13
GNAQ	GNAS	H3F3A	H3F3B	HDAC1	HIST1H3B	HIST1H3C	HNF1A	HOXB13	HRAS
IDH1	IDH2	INSR	IRF4	JAK1	JAK2	JAK3	KDM5C	KDM6A	KDR
KEAP1	KIF1B	KIT	KLF4	KMT2A	KMT2C	KMT2D	KRAS	LCK	LYN
LZTR1	MAML2	MAP2K1	MAP2K2	MAP2K4	MAP3K1	MAPK1	MAPK3	MAST1	MAST2
MAX	MED12	MEF2B	MEN1	MET	MET Exon 14 Skipping	MGA	MITF	MLH1	MLH3
MPL	MRE11	MSH2	MSH3	MSH6	MSMB	MST1R	MTOR	MUSK	MUTYH
MYB	MYC	MYCN	MYD88	NBN	NF1	NF2	NFE2L2	NFKBIA	NOTCH1
NOTCH2	NPM1	NRAS	NRG1	NSD1	NTHL1	NTRK1	NTRK2	NTRK3	NUMBL
NUTM1	PALB2	PARP1	PBRM1	PDGFRA	PDGFRB	PHOX2B	PIK3CA	PIK3CB	PIK3R1
PIK3R2	PIM1	PKN1	PMS1	PMS2	POLD1	POLD2	POLD3	POLD4	POLE
POLQ	POT1	PPARG	PPP2R1A	PPP2R2A	PRDM1	PRKACA	PRKAR1A	PRKCA	PRKCB
PRKDC	PTCH1	PTEN	PTPN11	RABL3	RAC1	RAD50	RAD51B	RAD51C	RAD51D
RAD54L	RAF1	RASA1	RB1	RELA	RET	RHOA	RNF43	ROS1	RPA1
RPA2	RPA3	RPA4	RSPO2	RSPO3	RUNX1	SDHA	SDHAF2	SDHB	SDHC
SDHD	SETD2	SF3B1	SMAD2	SMAD4	SMARCA4	SMARCB1	SMARCE1	SMO	SOCS1
SPEN	SPOP	SRC	SSBP1	STAG2	STAT3	STK11	SUFU	SUZ12	TCF7L2
TERT	TET2	TFE3	TFEB	THADA	TMEM127	TMPRSS2	TNFAIP3	TNFRSF14	TP53
TRAF7	TSC1	TSC2	U2AF1	VHL	WRN	WT1	XPO1	XRCC1	XRCC2
YES1

Tumor Profiling Options

The information below details the biomarkers analyzed by technology for the tumor type submitted. Tests may vary if insufficient tumor samples are submitted.

MI Profile™ – Multi-platform, solid tumor biomarker analysis

The technology platforms used and biomarkers tested may vary based on the tumor type submitted. Technologies include: NGS (whole exome sequencing for DNA mutations, copy number alterations, insertions/deletions, genomic signatures: LOH, MSI, TMB; and whole transcriptome sequencing for RNA fusions and variant transcripts), pyro sequencing, IHC, in situ hybridization.

MI Tumor Seek™ – NGS analysis

Whole exome sequencing for DNA mutations, copy number alterations, insertions/deletions, genomic signatures LOH, MSI, and TMB, and whole transcriptome sequencing for RNA fusions and variant transcripts. Add Immuno-Oncology IHC biomarkers (included in MI Profile):

PD-L1
MMR (MLH1, MSH2, MSH6, PMS2)

Next-Generation Sequencing (all tumor types)

Whole Exome Sequencing
Alterations	SNVs, Indels, CNAs
Genomic Signatures/Other	gLOH, MSI, TMB

Whole Transcriptome Sequencing
Alterations	Fusions, Variant Transcripts

Tumor Type:

Select tumor type to see specific tests to be performed

Tumor Type	Immunohistochemistry (IHC)	Other
Bladder	MMR, PD-L1 (SP142, 22c3)
Breast	AR, ER, Her2/Neu, Ki-67^, PD-L1 (22c3), PR, PTEN
Cancer of Unknown Primary – Female	AR, ER, Her2/Neu, MMR, PD-L1 (SP142)
Cancer of Unknown Primary – Male	AR, HER2/Neu, MMR, PD-L1 (SP142)
Cervical	ER, MMR, PD-L1 (22c3), PR
Cholangiocarcinoma/ Hepatobiliary	Her2/Neu, MMR, PD-L1 (SP142)	Her2 (Chromogenic in situ Hybridization)
Colorectal and Small Intestinal	Her2/Neu, MMR, PD-L1 (SP142), PTEN
Endometrial	ER, MMR, PD-L1 (SP142), PR, PTEN
Esophageal Cancer	Her2/Neu, MMR, PD-L1 (22c3)
Gastric/GEJ	Her2/Neu, MMR, PD-L1 (22c3)	EBER, Her2 (Chromogenic in situ Hybridization)
GIST	MMR, PD-L1 (SP142), PTEN
Glioma	PD-L1 (SP142)	MGMT Methylation (Pyrosequencing)
Head & Neck	MMR, p16, PD-L1 (22c3)	EBER, HPV (Chromogenic in situ Hybridization), HPV reflex to confirm p16 result
Kidney	MMR, PD-L1 (SP142)
Lymphoma/Leukemia
Melanoma	MMR, PD-L1 (SP142)
Merkel Cell	MMR, PD-L1 (SP142)
Neuroendocrine	MMR, PD-L1 (SP142)
Non-Small Cell Lung	ALK^†, PD-L1 (22c3, 28-8, SP142, SP263)
Ovarian	ER, FOLR1^#, MMR, PD-L1 (22c3), PR
Pancreatic	MMR, PD-L1 (SP142)
Prostate	AR, MMR, PD-L1 (SP142)
Salivary Gland	AR, Her2/Neu, MMR, PD-L1 (SP142)
Sarcoma	MMR, PD-L1 (SP142)
Small Cell Lung	PD-L1 (22c3)
Thyroid	MMR, PD-L1 (SP142)
Uterine Serous	ER, Her2/Neu, MMR, PD-L1 (SP142), PR, PTEN	Her2 (Chromogenic in situ Hybridization)
Vulvar Cancer (SCC)	MMR, PD-L1 (22c3)
Other Tumors	MMR, PD-L1 (SP142)
MMR = Mismatch Repair proteins: MLH1, MSH2, MSH6, PMS2 ^†ALK IHC only performed for NSCLC adenocarcinoma. ^#FOLR1 IHC performed for epithelial ovarian cancer. ^Ki-67 IHC only for early stage breast cancer. * Not available in all locations.

Order Profiling

Place an order today for a comprehensive, personalized Caris profiling report.

Caris applies the appropriate tumor-specific customizations standard with every order.
In certain instances, some biomarkers or genes ordered individually will not associate with commercially available cancer therapies or clinical trials.
For PD-L1 IHC testing, Dako antibodies 22c3, 28-8 and antibodies SP-142 and SP263 are used as appropriate.
For certain patients, HER2 testing is performed by Chromogenic in situ Hybridization, in addition to Next-Generation Sequencing.

Reflex Testing Menu

Comprehensive molecular profiling from Caris Life Sciences® assesses DNA, RNA, and proteins with multiple technologies including next-generation sequencing

Sufficient tumor content (>20% tumor nuclei) must be present to complete all analyses. If you have any questions, please contact Customer Support at (888) 979-8669.

Technical Information	IHC	CISH
Sample Requirements (see requisition for full details)	1 unstained slide at 4μm thickness from FFPE block, with evaluable tumor present, per IHC test	1 unstained slide at 4μm thickness from FFPE block, with at least 100 evaluable tumor cells present, per CISH test
Sensitivity/Specificity	>95%	>95%

Technical Information	NGS (Whole Exome – DNA)	NGS (Whole Transcriptome – RNA)
Sample Requirements	FFPE block or 10 unstained slides with a minimum of 20% malignant origin for DNA and 10% malignant origin for RNA. Needle biopsy is also acceptable (4-6 cores).
Tumor Enrichment (when necessary)	Microdissection to isolate and increase the number of cancer cells to improve test performance and increase the chance for successful testing from small tumor samples
Number of Genes	22,000+ genes	22,000+ genes
Average Depth of Coverage (DNA) Average Read Count (RNA)	1,000x for 719+ genes; 400-500x for all other genes	60 million reads
Positive Percent Agreement (PPA)	>95% for base substitutions at ≥ 5% mutant allele frequency; >95% for indels at ≥ 5% mutant allele frequency; >90% for copy number alterations (amplifications ≥ 6 copies)	>97%
Negative Percent Agreement (NPA)	>99%	>99%
Genomic Signatures/Other	Genomic Loss of Heterozygosity (gLOH) Microsatellite Instability (MSI) Tumor Mutational Burden (TMB)
* Not available in all locations.

ABL	ABL1	ACVR1	AIP	AKT1	AKT2	AKT3	ALK	AMER1	APC
AR	ARAF	ARHGAP26	ARHGAP35	ARID1A	ARID2	AR-V7	ASXL1	ATM	ATR
ATRX	AXIN1	AXIN2	AXL	B2M	BAP1	BARD1	BCL2	BCL9	BCOR
BCR	BLM	BMPR1A	BRAF	BRCA1	BRCA2	BRD3	BRD4	BRIP1	BTK
CALR	CARD11	CASP8	CBFB	CCND1	CCND2	CCND3	CD79B	CDC73	CDH1
CDK12	CDK4	CDK6	CDKN1B	CDKN2A	CHEK1	CHEK2	CIC	CREBBP	CSF1R
CTCF	CTNNA1	CTNNB1	CXCR4	CYLD	CYP17A1	DDR2	DICER1	DNMT3A	EGFR
EGFR vIII	EGLN1	ELF3	EP300	EPHA2	ERBB2	ERBB3	ERBB4	ERCC2	ERG
ESR1	ETV1	ETV4	ETV5	ETV6	EWSR1	EXO1	EZH2	FANCA	FANCB
FANCC	FANCD2	FANCE	FANCF	FANCG	FANCI	FANCL	FANCM	FAS	FAT1
FBXW7	FGFR1	FGFR2	FGFR3	FGFR4	FGR	FH	FLCN	FLT1	FLT3
FLT4	FOXA1	FOXL2	FUBP1	FYN	GALNT12	GATA3	GLI2	GNA11	GNA13
GNAQ	GNAS	H3F3A	H3F3B	HDAC1	HIST1H3B	HIST1H3C	HNF1A	HOXB13	HRAS
IDH1	IDH2	INSR	IRF4	JAK1	JAK2	JAK3	KDM5C	KDM6A	KDR
KEAP1	KIF1B	KIT	KLF4	KMT2A	KMT2C	KMT2D	KRAS	LCK	LYN
LZTR1	MAML2	MAP2K1	MAP2K2	MAP2K4	MAP3K1	MAPK1	MAPK3	MAST1	MAST2
MAX	MED12	MEF2B	MEN1	MET	MET Exon 14 Skipping	MGA	MITF	MLH1	MLH3
MPL	MRE11	MSH2	MSH3	MSH6	MSMB	MST1R	MTOR	MUSK	MUTYH
MYB	MYC	MYCN	MYD88	NBN	NF1	NF2	NFE2L2	NFKBIA	NOTCH1
NOTCH2	NPM1	NRAS	NRG1	NSD1	NTHL1	NTRK1	NTRK2	NTRK3	NUMBL
NUTM1	PALB2	PARP1	PBRM1	PDGFRA	PDGFRB	PHOX2B	PIK3CA	PIK3CB	PIK3R1
PIK3R2	PIM1	PKN1	PMS1	PMS2	POLD1	POLD2	POLD3	POLD4	POLE
POLQ	POT1	PPARG	PPP2R1A	PPP2R2A	PRDM1	PRKACA	PRKAR1A	PRKCA	PRKCB
PRKDC	PTCH1	PTEN	PTPN11	RABL3	RAC1	RAD50	RAD51B	RAD51C	RAD51D
RAD54L	RAF1	RASA1	RB1	RELA	RET	RHOA	RNF43	ROS1	RPA1
RPA2	RPA3	RPA4	RSPO2	RSPO3	RUNX1	SDHA	SDHAF2	SDHB	SDHC
SDHD	SETD2	SF3B1	SMAD2	SMAD4	SMARCA4	SMARCB1	SMARCE1	SMO	SOCS1
SPEN	SPOP	SRC	SSBP1	STAG2	STAT3	STK11	SUFU	SUZ12	TCF7L2
TERT	TET2	TFE3	TFEB	THADA	TMEM127	TMPRSS2	TNFAIP3	TNFRSF14	TP53
TRAF7	TSC1	TSC2	U2AF1	VHL	WRN	WT1	XPO1	XRCC1	XRCC2
YES1

Tumor Profiling Options

The information below details the biomarkers analyzed by technology for the tumor type submitted. Tests may vary if insufficient tumor samples are submitted.

MI Tumor Seek^{^TM}

Next-Generation Sequencing analysis. Whole exome sequencing and whole transcriptome sequencing are performed.

AI-Powered Molecular Signatures

Caris GPSai^™*
Cancer type similarity assessment that is intended to help identify the tumor of origin by comparing the molecular characteristics of the patient's tumor against other tumors in the Caris database.

Caris FOLFIRSTai^™*
Chemotherapy response predictor that is intended to gauge a mCRC patient's likelihood of benefit from first-line FOLFOX+BV followed by FOLFIRI+BV, versus FOLFIRI+BV followed by FOLFOX+BV treatment.

Next-Generation Sequencing (all tumor types)

Whole Exome Sequencing
Alterations	SNVs, Indels, CNAs, Karyotyping,* Viruses*
Genomic Signatures/Other	gLOH, MSI, TMB, HLA Genotyping*

Whole Transcriptome Sequencing
Alterations	Fusions, Variant Transcripts, Gene Expression*

Order Profiling

Place an order today for a comprehensive, personalized Caris profiling report.

Caris applies the appropriate tumor-specific customizations standard with every order.
In certain instances, some biomarkers or genes ordered individually will not associate with commercially available cancer therapies or clinical trials.
For PD-L1 IHC testing, Dako antibodies 22c3, 28-8 and antibodies SP-142 and SP263 are used as appropriate.
For certain patients, HER2 testing is performed by Chromogenic in situ Hybridization, in addition to Next-Generation Sequencing.

Reflex Testing Menu

Comprehensive molecular profiling from Caris Life Sciences® assesses DNA, RNA, and proteins with multiple technologies including next-generation sequencing

Sufficient tumor content (>20% tumor nuclei) must be present to complete all analyses. If you have any questions, please contact Customer Support at (888) 979-8669.

Technical Information	NGS (Whole Exome – DNA)	NGS (Whole Transcriptome – RNA)
Sample Requirements	FFPE block or 10 unstained slides with a minimum of 20% malignant origin for DNA and 10% malignant origin for RNA. Needle biopsy is also acceptable (4-6 cores).
Tumor Enrichment (when necessary)	Microdissection to isolate and increase the number of cancer cells to improve test performance and increase the chance for successful testing from small tumor samples
Number of Genes	22,000+ genes	22,000+ genes
Average Depth of Coverage (DNA) Average Read Count (RNA)	1,000x for 719+ genes; 400-500x for all other genes	60 million reads
Positive Percent Agreement (PPA)	>95% for base substitutions at ≥ 5% mutant allele frequency; >95% for indels at ≥ 5% mutant allele frequency; >90% for copy number alterations (amplifications ≥ 6 copies)	>97%
Negative Percent Agreement (NPA)	>99%	>99%
Genomic Signatures/Other	Genomic Loss of Heterozygosity (gLOH) Microsatellite Instability (MSI) Tumor Mutational Burden (TMB) Human Leukocyte Antigen (HLA) Genotype*
* Not available in all locations.

ABL	ABL1	ACVR1	AIP	AKT1	AKT2	AKT3	ALK	AMER1	APC
AR	ARAF	ARHGAP26	ARHGAP35	ARID1A	ARID2	AR-V7	ASXL1	ATM	ATR
ATRX	AXIN1	AXIN2	AXL	B2M	BAP1	BARD1	BCL2	BCL9	BCOR
BCR	BLM	BMPR1A	BRAF	BRCA1	BRCA2	BRD3	BRD4	BRIP1	BTK
CALR	CARD11	CASP8	CBFB	CCND1	CCND2	CCND3	CD79B	CDC73	CDH1
CDK12	CDK4	CDK6	CDKN1B	CDKN2A	CHEK1	CHEK2	CIC	CREBBP	CSF1R
CTCF	CTNNA1	CTNNB1	CXCR4	CYLD	CYP17A1	DDR2	DICER1	DNMT3A	EGFR
EGFR vIII	EGLN1	ELF3	EP300	EPHA2	ERBB2	ERBB3	ERBB4	ERCC2	ERG
ESR1	ETV1	ETV4	ETV5	ETV6	EWSR1	EXO1	EZH2	FANCA	FANCB
FANCC	FANCD2	FANCE	FANCF	FANCG	FANCI	FANCL	FANCM	FAS	FAT1
FBXW7	FGFR1	FGFR2	FGFR3	FGFR4	FGR	FH	FLCN	FLT1	FLT3
FLT4	FOXA1	FOXL2	FUBP1	FYN	GALNT12	GATA3	GLI2	GNA11	GNA13
GNAQ	GNAS	H3F3A	H3F3B	HDAC1	HIST1H3B	HIST1H3C	HNF1A	HOXB13	HRAS
IDH1	IDH2	INSR	IRF4	JAK1	JAK2	JAK3	KDM5C	KDM6A	KDR
KEAP1	KIF1B	KIT	KLF4	KMT2A	KMT2C	KMT2D	KRAS	LCK	LYN
LZTR1	MAML2	MAP2K1	MAP2K2	MAP2K4	MAP3K1	MAPK1	MAPK3	MAST1	MAST2
MAX	MED12	MEF2B	MEN1	MET	MET Exon 14 Skipping	MGA	MITF	MLH1	MLH3
MPL	MRE11	MSH2	MSH3	MSH6	MSMB	MST1R	MTOR	MUSK	MUTYH
MYB	MYC	MYCN	MYD88	NBN	NF1	NF2	NFE2L2	NFKBIA	NOTCH1
NOTCH2	NPM1	NRAS	NRG1	NSD1	NTHL1	NTRK1	NTRK2	NTRK3	NUMBL
NUTM1	PALB2	PARP1	PBRM1	PDGFRA	PDGFRB	PHOX2B	PIK3CA	PIK3CB	PIK3R1
PIK3R2	PIM1	PKN1	PMS1	PMS2	POLD1	POLD2	POLD3	POLD4	POLE
POLQ	POT1	PPARG	PPP2R1A	PPP2R2A	PRDM1	PRKACA	PRKAR1A	PRKCA	PRKCB
PRKDC	PTCH1	PTEN	PTPN11	RABL3	RAC1	RAD50	RAD51B	RAD51C	RAD51D
RAD54L	RAF1	RASA1	RB1	RELA	RET	RHOA	RNF43	ROS1	RPA1
RPA2	RPA3	RPA4	RSPO2	RSPO3	RUNX1	SDHA	SDHAF2	SDHB	SDHC
SDHD	SETD2	SF3B1	SMAD2	SMAD4	SMARCA4	SMARCB1	SMARCE1	SMO	SOCS1
SPEN	SPOP	SRC	SSBP1	STAG2	STAT3	STK11	SUFU	SUZ12	TCF7L2
TERT	TET2	TFE3	TFEB	THADA	TMEM127	TMPRSS2	TNFAIP3	TNFRSF14	TP53
TRAF7	TSC1	TSC2	U2AF1	VHL	WRN	WT1	XPO1	XRCC1	XRCC2
YES1

Tumor Profiling Options

The information below details the biomarkers analyzed by technology for the tumor type submitted. Tests may vary if insufficient tumor samples are submitted.

MI Profile Comprehensive Testing

MI Tumor Seek Hybrid^{^TM} (NGS-based WES and WTS) plus Immunohistochemistry and Other Tests by Tumor Type. Caris FOLFIRSTai^{^TM} reported for mCRC cases.

Next-Generation Sequencing Only

MI Tumor Seek Hybrid^{^TM}, including NGS-based whole exome sequencing and whole transcriptome sequencing. Caris FOLFIRSTai™ reported for mCRC cases.

Next-Generation Sequencing (all tumor types)

Whole Exome Sequencing
Alterations	SNVs, Indels, CNAs, Karyotyping, Viruses
Genomic Signatures/Other	gLOH, MSI, TMB, HLA Genotyping, Homologous Recombination Deficiency (HRD)

Whole Transcriptome Sequencing
Alterations	Fusions, Variant Transcripts, Gene Expression*

AI-Powered Molecular Signatures

Caris GPSai^™*
Cancer type similarity assessment that is intended to help identify the tumor of origin by comparing the molecular characteristics of the patient's tumor against other tumors in the Caris database.

Caris FOLFIRSTai^™*
Chemotherapy response predictor that is intended to gauge a mCRC patient's likelihood of benefit from first-line FOLFOX+BV followed by FOLFIRI+BV, versus FOLFIRI+BV followed by FOLFOX+BV treatment.

Tumor Type:

Select tumor type to see specific tests to be performed

Tumor Type	Immunohistochemistry (IHC)	Other
Bladder	MMR, PD-L1 (SP142, 22c3)
Breast	AR, ER, Her2/Neu, Ki-67^, PD-L1 (22c3), PR, PTEN
Cancer of Unknown Primary – Female	AR, ER, Her2/Neu, MMR, PD-L1 (SP142)
Cancer of Unknown Primary – Male	AR, HER2/Neu, MMR, PD-L1 (SP142)
Cervical	ER, MMR, PD-L1 (22c3), PR
Cholangiocarcinoma/ Hepatobiliary	Her2/Neu, MMR, PD-L1 (SP142)	Her2 (Chromogenic in situ Hybridization)
Colorectal and Small Intestinal	Her2/Neu, MMR, PD-L1 (SP142), PTEN
Endometrial	ER, MMR, PD-L1 (SP142), PR, PTEN
Esophageal Cancer	Her2/Neu, MMR, PD-L1 (22c3)
Gastric/GEJ	Her2/Neu, MMR, PD-L1 (22c3)	EBER, Her2 (Chromogenic in situ Hybridization)
GIST	MMR, PD-L1 (SP142), PTEN
Glioma	PD-L1 (SP142)	MGMT Methylation (Pyrosequencing)
Head & Neck	MMR, p16, PD-L1 (22c3)	EBER, HPV (Chromogenic in situ Hybridization), HPV reflex to confirm p16 result
Kidney	MMR, PD-L1 (SP142)
Lymphoma/Leukemia
Melanoma	MMR, PD-L1 (SP142)
Merkel Cell	MMR, PD-L1 (SP142)
Neuroendocrine	MMR, PD-L1 (SP142)
Non-Small Cell Lung	ALK^†, PD-L1 (22c3, 28-8, SP142, SP263)
Ovarian	ER, FOLR1^#, MMR, PD-L1 (22c3), PR
Pancreatic	MMR, PD-L1 (SP142)
Prostate	AR, MMR, PD-L1 (SP142)
Salivary Gland	AR, Her2/Neu, MMR, PD-L1 (SP142)
Sarcoma	MMR, PD-L1 (SP142)
Small Cell Lung	PD-L1 (22c3)
Thyroid	MMR, PD-L1 (SP142)
Uterine Serous	ER, Her2/Neu, MMR, PD-L1 (SP142), PR, PTEN	Her2 (Chromogenic in situ Hybridization)
Vulvar Cancer (SCC)	MMR, PD-L1 (22c3)
Other Tumors	MMR, PD-L1 (SP142)
MMR = Mismatch Repair proteins: MLH1, MSH2, MSH6, PMS2 ^†ALK IHC only performed for NSCLC adenocarcinoma. #FOLR1 IHC and HRD Status only performed for epithelial ovarian cancer. ^Ki-67 IHC only for early stage breast cancer. * Not available in all locations.

Order Profiling

Place an order today for a comprehensive, personalized Caris profiling report.

Caris applies the appropriate tumor-specific customizations standard with every order.
In certain instances, some biomarkers or genes ordered individually will not associate with commercially available cancer therapies or clinical trials.
For PD-L1 IHC testing, Dako antibodies 22c3, 28-8 and antibodies SP-142 and SP263 are used as appropriate.
For certain patients, HER2 testing is performed by Chromogenic in situ Hybridization, in addition to Next-Generation Sequencing.

Reflex Testing Menu

Comprehensive molecular profiling from Caris Life Sciences® assesses DNA, RNA, and proteins with multiple technologies including next-generation sequencing

Sufficient tumor content (>20% tumor nuclei) must be present to complete all analyses. If you have any questions, please contact Customer Support at (888) 979-8669.

Technical Information	IHC	CISH
Sample Requirements (see requisition for full details)	1 unstained slide at 4μm thickness from FFPE block, with evaluable tumor present, per IHC test	1 unstained slide at 4μm thickness from FFPE block, with at least 100 evaluable tumor cells present, per CISH test
Sensitivity/Specificity	>95%	>95%

Technical Information	NGS (Whole Exome – DNA)	NGS (Whole Transcriptome – RNA)
Sample Requirements	FFPE block or 10 unstained slides with a minimum of 20% malignant origin for DNA and 10% malignant origin for RNA. Needle biopsy is also acceptable (4-6 cores).
Tumor Enrichment (when necessary)	Microdissection to isolate and increase the number of cancer cells to improve test performance and increase the chance for successful testing from small tumor samples
Number of Genes	23,000+ genes	23,000+ genes
Average Depth of Coverage (DNA) Average Read Count (RNA)	800x for clinical genes	23 million reads
Positive Percent Agreement (PPA)	>95% for base substitutions at ≥ 5% mutant allele frequency; >95% for indels at ≥ 5% mutant allele frequency; >90% for copy number alterations (amplifications ≥ 6 copies)	>97%
Negative Percent Agreement (NPA)	>99%	>99%
Viruses*	HPV 16 & 18 (Head & Neck, Anal, Genital, CUP)
Genomic Signatures/Other	Genomic Loss of Heterozygosity (gLOH) Homologous Recombination Deficiency (HRD)* Microsatellite Instability (MSI) Tumor Mutational Burden (TMB) Human Leukocyte Antigen (HLA) Genotype*
* Not available in all locations.

ABL	ABL1	ACVR1	AIP	AKT1	AKT2	AKT3	ALK	AMER1	APC
AR	ARAF	ARHGAP26	ARHGAP35	ARID1A	ARID2	AR-V7	ASXL1	ATM	ATR
ATRX	AXIN1	AXIN2	AXL	B2M	BAP1	BARD1	BCL2	BCL9	BCOR
BCR	BLM	BMPR1A	BRAF	BRCA1	BRCA2	BRD3	BRD4	BRIP1	BTK
CALR	CARD11	CASP8	CBFB	CCND1	CCND2	CCND3	CD79B	CDC73	CDH1
CDK12	CDK4	CDK6	CDKN1B	CDKN2A	CHEK1	CHEK2	CIC	CREBBP	CSF1R
CTCF	CTNNA1	CTNNB1	CXCR4	CYLD	CYP17A1	DDR2	DICER1	DNMT3A	EGFR
EGFR vIII	EGLN1	ELF3	EP300	EPHA2	ERBB2	ERBB3	ERBB4	ERCC2	ERG
ESR1	ETV1	ETV4	ETV5	ETV6	EWSR1	EXO1	EZH2	FANCA	FANCB
FANCC	FANCD2	FANCE	FANCF	FANCG	FANCI	FANCL	FANCM	FAS	FAT1
FBXW7	FGFR1	FGFR2	FGFR3	FGFR4	FGR	FH	FLCN	FLT1	FLT3
FLT4	FOXA1	FOXL2	FUBP1	FYN	GALNT12	GATA3	GLI2	GNA11	GNA13
GNAQ	GNAS	H3F3A	H3F3B	HDAC1	HIST1H3B	HIST1H3C	HNF1A	HOXB13	HRAS
IDH1	IDH2	INSR	IRF4	JAK1	JAK2	JAK3	KDM5C	KDM6A	KDR
KEAP1	KIF1B	KIT	KLF4	KMT2A	KMT2C	KMT2D	KRAS	LCK	LYN
LZTR1	MAML2	MAP2K1	MAP2K2	MAP2K4	MAP3K1	MAPK1	MAPK3	MAST1	MAST2
MAX	MED12	MEF2B	MEN1	MET	MET Exon 14 Skipping	MGA	MITF	MLH1	MLH3
MPL	MRE11	MSH2	MSH3	MSH6	MSMB	MST1R	MTOR	MUSK	MUTYH
MYB	MYC	MYCN	MYD88	NBN	NF1	NF2	NFE2L2	NFKBIA	NOTCH1
NOTCH2	NPM1	NRAS	NRG1	NSD1	NTHL1	NTRK1	NTRK2	NTRK3	NUMBL
NUTM1	PALB2	PARP1	PBRM1	PDGFRA	PDGFRB	PHOX2B	PIK3CA	PIK3CB	PIK3R1
PIK3R2	PIM1	PKN1	PMS1	PMS2	POLD1	POLD2	POLD3	POLD4	POLE
POLQ	POT1	PPARG	PPP2R1A	PPP2R2A	PRDM1	PRKACA	PRKAR1A	PRKCA	PRKCB
PRKDC	PTCH1	PTEN	PTPN11	RABL3	RAC1	RAD50	RAD51B	RAD51C	RAD51D
RAD54L	RAF1	RASA1	RB1	RELA	RET	RHOA	RNF43	ROS1	RPA1
RPA2	RPA3	RPA4	RSPO2	RSPO3	RUNX1	SDHA	SDHAF2	SDHB	SDHC
SDHD	SETD2	SF3B1	SMAD2	SMAD4	SMARCA4	SMARCB1	SMARCE1	SMO	SOCS1
SPEN	SPOP	SRC	SSBP1	STAG2	STAT3	STK11	SUFU	SUZ12	TCF7L2
TERT	TET2	TFE3	TFEB	THADA	TMEM127	TMPRSS2	TNFAIP3	TNFRSF14	TP53
TRAF7	TSC1	TSC2	U2AF1	VHL	WRN	WT1	XPO1	XRCC1	XRCC2
YES1

Technical Specifications

Sufficient tumor content (>20% tumor nuclei) must be present to complete all analysis. If you have questions, please contact Customer Support at (888) 979-8669.

FFPE/SLIDE TISSUE

Tumor content: >20% tumor nuclei

Paraffin Block (Preferred)

Formalin fixed tissue block (including core-needle biopsies, fine-needle aspirates or malignant fluid)

Unstained Slides

25 slides

FRESH TISSUE

10% neutral buffered formalin

Four to six (4-6) biopsies with 18 gauge needle preferred

Six to ten (6-10) biopsies with 22 needle accepted

Caris Report Specs

Biomarker Analysis by Tumor Type

The information below details the biomarkers analyzed by technology for the tumor type submitted. Tests may vary if insufficient tumor samples are submitted.

Download Profile Menu for US and Intl PDF >

Download Profile Menu for New York State PDF >

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Looking for a Specific Gene?

Use our full gene search to verify that it is included in Caris profiling, or browse the list of genes most commonly associated with cancer.

Search Genes >

Expand for a list of genes most commonly associated with cancer.

General Profile Menu (see above links for market specific menus)

All Biomarker Analysis includes:

Whole Exome Sequencing (WES)

DNA

Genomic
Signatures

Others

Point Mutations

Indels

Copy Number Alterations

HPV 16 and 18

MSI

TMB

LOH

HLA*

*Not available in New York state

Whole Transcriptome Sequencing (WTS)

RNA

Fusion Analysis

Variant Transcripts

Additional Testing:

Select tumor type to see specific tests to be performed.

Tumor Type:

No tumor selected

Tumor Type:

Select tumor type to see specific tests to be performed

Additional Information:

Caris applies the appropriate tumor-specific customizations standard with every order.
In certain instances, some biomarkers or genes ordered individually will not associate with commercially available cancer therapies or clinical trials.
For PD-L1 IHC testing, Dako antibodies 22c3, 28-8 and antibodies SP-142 and SP263 are used as appropriate.
For certain patients, HER2 testing is performed by Chromogenic in situ Hybridization, in addition to Next-Generation Sequencing.

REFLEX TESTING MENU >

Tumor Type:

Select tumor type to see specific tests to be performed

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Testing Menu

Comprehensive Tumor Profiling

DNA

RNA

Protein

Tumor Profiling Options

MI Profile Comprehensive Testing

Next-Generation Sequencing Only

Next-Generation Sequencing (all tumor types)

AI-Powered Molecular Signatures

Next-Generation Sequencing

Immunohistochemistry (IHC)

Other

Other Testing by Tumor Type

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Additional Information

Reflex Testing Menu

Technical Specifications

Genes Most Commonly Associated with Cancer

Tumor Profiling Options

MI Profile™ – Multi-platform, solid tumor biomarker analysis

MI Tumor Seek™ – NGS analysis

Next-Generation Sequencing (all tumor types)

Next-Generation Sequencing

Immunohistochemistry (IHC)

Other

Other Testing by Tumor Type

Order Profiling

Additional Information

Reflex Testing Menu

Technical Specifications

Genes Most Commonly Associated with Cancer

Tumor Profiling Options

MI Tumor SeekTM

AI-Powered Molecular Signatures

Next-Generation Sequencing (all tumor types)

Order Profiling

Additional Information

Reflex Testing Menu

Technical Specifications

Genes Most Commonly Associated with Cancer

Tumor Profiling Options

MI Profile Comprehensive Testing

Next-Generation Sequencing Only

Next-Generation Sequencing (all tumor types)

AI-Powered Molecular Signatures

Next-Generation Sequencing

Immunohistochemistry (IHC)

Other

Other Testing by Tumor Type

Order Profiling

Additional Information

Reflex Testing Menu

Technical Specifications

Genes Most Commonly Associated with Cancer

Technical Specifications

FFPE/SLIDE TISSUE

FRESH TISSUE

Caris Report Specs

Biomarker Analysis by Tumor Type

Looking for a Specific Gene?

General Profile Menu (see above links for market specific menus)

All Biomarker Analysis includes:

Additional Testing:

Next-Generation Sequencing

Immunohistochemistry (IHC)

Other

Next-Generation Sequencing

Immunohistochemistry (IHC)

Other

Next-Generation Sequencing

Immunohistochemistry (IHC)

Other

Request Clinical/Scientific MSL Support

Order a test

MI Tumor Seek^{^TM}