Circulating Nucleic Acid
Sequencing (cNAS)
Biomarker Analysis (including resistance mutations)
Plasma: cfDNA, cfRNA
White Blood Cells: gDNA, mRNA
Tumor-Derived
Incidental CHIP
Incidental Germline†
23,000+ 8,000x (raw average for clinically relevant genes)
Whole Exome
Whole Transcriptome
SNV InDel CNA Fusions
bTMB HLA Genotype MSI
Two Tubes Whole Blood
Compared to matched tissue collected within 30 days; based on ≥5 ng of cNAS input.
Clinically Actionable SNV and InDel:
Sensitivity 93.8%
Specificity >99.9%
PPV 96.8%
LOD 0.1% VAF
Incidental Germline† :
Sensitivity >99%
Specificity >99%
PPV >99%
†Not a replacement for comprehensive germline testing. Incidental pathogenic alterations detected in ACMG recognized cancer genes are reported. Negative results do not imply the patient does not harbor a germline mutation.
Caris Assure™ is intended for patients with previously diagnosed solid malignant neoplasms when tissue is not feasible and is to be used by qualified healthcare professionals. RNA results are intended for investigational purposes only. Not available in all locations.
By distinguishing somatic (acquired) variants from incidental CHIP or incidental germline results, Caris Assure provides confidence in therapy decisions and avoidance of off-target drugs.
Clonal hematopoiesis of indeterminate potential (CHIP) mutations from aging white blood cells may cause false positive results in blood-based assays. Caris Assure distinguishes CHIP from somatic tumor mutations to improve accuracy.
Caris Assure analyzes genomic DNA from circulating white blood cells found in the buffy coat and can distinguish incidental germline† mutations from somatic mutations.
Sample Requirements (see requisition for full details) | 2 x 10 mL tubes whole blood |
Number of Genes | 23,000+ genes |
Average Depth of Coverage (DNA) | 8,000x (raw average for clinically relevant genes) |
Sensitivity | 93.8% for SNV and InDel >99.9% for Incidental Germline |
Specificity | >99.9% for SNV and InDel >99% for Incidental Germline |
Alterations | SNV, InDel, CNA, Fusions |
Genomic Signatures/Other | Blood Tumor Mutational Burden (bTMB) Human Leukocyte Antigen (HLA) Genotype Microsatellite Instability (MSI) |
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 | FOLR1 | 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 | Ki-67 | 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 |
Sample Requirements (see requisition for full details) | 2 x 10 mL tubes whole blood |
Number of Genes | 23,000+ genes |
Average Depth of Coverage (DNA) | 8,000x (raw average for clinically relevant genes) |
Sensitivity |
= 93.8% for SNV and InDel = >99.9% for Incidental Germline |
Specificity |
= >99.9% for SNV and InDel = >99% for Incidental Germline |
Alterations | SNV, INDEL, CNA, Fusions |
Genomic Signatures/Other |
Blood Tumor Mutational Burden (bTMB) Human Leukocyte Antigen (HLA) Genotype Microsatellite Instability (MSI) |
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 |
FOLR1 | 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 | Ki-67 | 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 |
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