SIGNOMETM Tumor Profiling System

Comprehensive Detection of Cancer Somatic Variants

The SIGNOMETM Tumor Profiling System is a complete, comprehensive solution for somatic variant detection in cancer. The system includes a complete set of reagents to enable the wet laboratory chemistry, coupled with a comprehensive data analysis to produce detailed analysis and reports.

Laboratories can use the SIGNOMETM Tumor Profiling System to accurately detect and analyze all alterations in single – and double – stranded DNA from low volume and poor quality tumor tissue.

In addition to its standard panel of 130 cancer genes, SIGNOME can be customized to analyze any genes of interest.

The SIGNOMETM Tumor Profiling System

Using COMPASSTM, scientists have everything at their fingertips to identify significant alterations from precious tumor FFPE samples using less material while producing the highest quality data.

LIBRARY
PREPARATION
MODULE I

complete set of reagents to prepare extracted dna for sequencing

LIBRARY
PREPARATION
MODULE II

gene specific content powered by Oligo Selective Sequencing or OS-SeqTM

DNA STANDARDS
& CONTROL
MODULE

standards ensure “ground truth” variant detection

STRATUSTM
ANALYSIS
MODULE

cloud based uploading and analysis tool

CLINICAL ANNOTATION
&
REPORTING MODULES

identify therapeutic options

MOLECULAR
TUMOR BOARD
MODULE

provide clinical interpretation of results
SIGNOMETM OTHER COMMERCIAL REAGENTS TOMA OS-SEQTM ADVANTAGE
CANCER GENE COVERAGE Comprehensive – complete sequencing of every exon interrogated Limited – “Hot Spot” methods exclude up to 90% of each gene and are not able to report all variant types Detects all mutation types: single nucleotide variations, short indels, and copy number alterations
SAMPLE - EFFICIENT High – DNA input as low as 10ng from FFPE (formalin-fixed paraffin embedded tissue) Requires large quantities of DNA input – exhausts precious oncology patient samples - high rate of rejection or QNS Preserve precious patient sample – DNA inputs as low as 10ng and reduce samples rejected due to "quantity not sufficient" QNS
SENSITIVE VARIANT DETECTION Complete – High sensitivity for all variant types, down to 2% for single nucleotide variants (SNVs) and 94% concordance to FISH for copy number (CNAs) False Negatives – misses majority of copy number alterations, the largest class of actionable genomic alterations in cancer Dramatically increases clinically significant findings
EFFICIENCY High Yield – from ultra efficient adaptor ligation Low Yield – highly dependant upon PCR to generate sufficient library for sequencing Highly efficient library preparation method preserves precious sample
PCR USED IN DNA PREPARATION Minimal – library preparation method only amplifies targets of interest; eliminates whole genome PCR High – amplifies “whole genome” PCR creating artifacts and errors, reducing specificity and causing analysis issues No “whole genome,” PCR dramatically reduces errors common to other methods
SEQUENCING DEPTH 500X – up to 6 concurrent samples on an Illumina MiSeq LOW – misses key mutations and increases false negatives Minimizes false negatives
ANALYSIS Simple – TOMA Stratus™ easy, accurate calling of somatic alterations, including CNAs None – limited assay specific bioinformatics; not designed for somatic alteration detection Simple – Stratus provides the easiest, high accuracy variant calls including copy number
TIMING Fast – DNA library complete in 16 hours (3 hrs hands on time) Slow – takes 2-3 days Generates a sequencing library in a single day

TOMA OS-SEQTM 130 CANCER GENE PANEL

For Research Use Only. Not for use in diagnostic procedures.

ABL1 BRCA1 CDKN2B FGFR1 KIT NBN PTPN11 SYK
ABL2 BRCA2 CEBPA FGFR2 KRAS NF1 RAD50 TET2
AKT1 BTK CSF1R FGFR3 MAP2K1 NFE2L2 RB1 TP53
AKT3 CALR CTNNB1 FGFR4 MAP2K2 NOTCH1 RET TPMT
ALK CCND1 CYP2D6 FLT3 MAPK1 NPM1 RICTOR TSC1
APC CCND2 DDR2 GNA11 MCL1 NRAS RNF43 TSC2
AR CCND3 DNMT3A GNAQ MDM2 NTRK1 ROS1 U2AF1
ARAF CD274 DPYD GNAS MET NTRK2 RPTOR UGT1A1
ASXL1 CDH1 EGFR H3F3A MLH1 NTRK3 RUNX1 VEGFA
ATM CDK12 EMSY HNF1A MPL PALB2 SF3B1 VHL
ATR CDK2 ERBB2 HRAS MRE11A PARP1 SLCO1B1 WT1
ATRX CDK4 ERBB3 IDH1 MSH2 PARP2 SMAD4
AURKA CDK5 ERBB4 IDH2 MSH6 PDGFRA SMARCB1
AURKB CDK6 ERCC2 IGF1R MTOR PIK3CA SMO
AXL CDK8 ESR1 JAK2 MUTYH PMS2 SRC
BCL2 CDK9 ETV6 JAK3 MYC PTCH1 SRSF2
BRAF CDKN2A EZH2 KDR MYD88 PTEN STK11
ABL1 BRCA1 CDKN2B FGFR1 KIT NBN PTPN11 SYK
ABL2 BRCA2 CEBPA FGFR2 KRAS NF1 RAD50 TET2
AKT1 BTK CSF1R FGFR3 MAP2K1 NFE2L2 RB1 TP53
AKT3 CALR CTNNB1 FGFR4 MAP2K2 NOTCH1 RET TPMT
ALK CCND1 CYP2D6 FLT3 MAPK1 NPM1 RICTOR TSC1
APC CCND2 DDR2 GNA11 MCL1 NRAS RNF43 TSC2
AR CCND3 DNMT3A GNAQ MDM2 NTRK1 ROS1 U2AF1
ARAF CD274 DPYD GNAS MET NTRK2 RPTOR UGT1A1
ASXL1 CDH1 EGFR H3F3A MLH1 NTRK3 RUNX1 VEGFA
ATM CDK12 EMSY HNF1A MPL PALB2 SF3B1 VHL
ATR CDK2 ERBB2 HRAS MRE11A PARP1 SLCO1B1 WT1
ATRX CDK4 ERBB3 IDH1 MSH2 PARP2 SMAD4
AURKA CDK5 ERBB4 IDH2 MSH6 PDGFRA SMARCB1
AURKB CDK6 ERCC2 IGF1R MTOR PIK3CA SMO
AXL CDK8 ESR1 JAK2 MUTYH PMS2 SRC
BCL2 CDK9 ETV6 JAK3 MYC PTCH1 SRSF2
BRAF CDKN2A EZH2 KDR MYD88 PTEN STK11
ABL1 BRCA1 CDKN2B FGFR1 KIT NBN PTPN11 SYK
ABL2 BRCA2 CEBPA FGFR2 KRAS NF1 RAD50 TET2
AKT1 BTK CSF1R FGFR3 MAP2K1 NFE2L2 RB1 TP53
AKT3 CALR CTNNB1 FGFR4 MAP2K2 NOTCH1 RET TPMT
ALK CCND1 CYP2D6 FLT3 MAPK1 NPM1 RICTOR TSC1
APC CCND2 DDR2 GNA11 MCL1 NRAS RNF43 TSC2
AR CCND3 DNMT3A GNAQ MDM2 NTRK1 ROS1 U2AF1
ARAF CD274 DPYD GNAS MET NTRK2 RPTOR UGT1A1
ASXL1 CDH1 EGFR H3F3A MLH1 NTRK3 RUNX1 VEGFA
ATM CDK12 EMSY HNF1A MPL PALB2 SF3B1 VHL
ATR CDK2 ERBB2 HRAS MRE11A PARP1 SLCO1B1 WT1
ATRX CDK4 ERBB3 IDH1 MSH2 PARP2 SMAD4
AURKA CDK5 ERBB4 IDH2 MSH6 PDGFRA SMARCB1
AURKB CDK6 ERCC2 IGF1R MTOR PIK3CA SMO
AXL CDK8 ESR1 JAK2 MUTYH PMS2 SRC
BCL2 CDK9 ETV6 JAK3 MYC PTCH1 SRSF2
BRAF CDKN2A EZH2 KDR MYD88 PTEN STK11
ABL1 BRCA1 CDKN2B FGFR1 KIT NBN PTPN11 SYK
ABL2 BRCA2 CEBPA FGFR2 KRAS NF1 RAD50 TET2
AKT1 BTK CSF1R FGFR3 MAP2K1 NFE2L2 RB1 TP53
AKT3 CALR CTNNB1 FGFR4 MAP2K2 NOTCH1 RET TPMT
ALK CCND1 CYP2D6 FLT3 MAPK1 NPM1 RICTOR TSC1
APC CCND2 DDR2 GNA11 MCL1 NRAS RNF43 TSC2
AR CCND3 DNMT3A GNAQ MDM2 NTRK1 ROS1 U2AF1
ARAF CD274 DPYD GNAS MET NTRK2 RPTOR UGT1A1
ASXL1 CDH1 EGFR H3F3A MLH1 NTRK3 RUNX1 VEGFA
ATM CDK12 EMSY HNF1A MPL PALB2 SF3B1 VHL
ATR CDK2 ERBB2 HRAS MRE11A PARP1 SLCO1B1 WT1
ATRX CDK4 ERBB3 IDH1 MSH2 PARP2 SMAD4
AURKA CDK5 ERBB4 IDH2 MSH6 PDGFRA SMARCB1
AURKB CDK6 ERCC2 IGF1R MTOR PIK3CA SMO
AXL CDK8 ESR1 JAK2 MUTYH PMS2 SRC
BCL2 CDK9 ETV6 JAK3 MYC PTCH1 SRSF2
BRAF CDKN2A EZH2 KDR MYD88 PTEN STK11
+ 130 Gene Cancer Panel
ABL1 BRCA1 CDKN2B FGFR1 KIT NBN PTPN11 SYK
ABL2 BRCA2 CEBPA FGFR2 KRAS NF1 RAD50 TET2
AKT1 BTK CSF1R FGFR3 MAP2K1 NFE2L2 RB1 TP53
AKT3 CALR CTNNB1 FGFR4 MAP2K2 NOTCH1 RET TPMT
ALK CCND1 CYP2D6 FLT3 MAPK1 NPM1 RICTOR TSC1
APC CCND2 DDR2 GNA11 MCL1 NRAS RNF43 TSC2
AR CCND3 DNMT3A GNAQ MDM2 NTRK1 ROS1 U2AF1
ARAF CD274 DPYD GNAS MET NTRK2 RPTOR UGT1A1
ASXL1 CDH1 EGFR H3F3A MLH1 NTRK3 RUNX1 VEGFA
ATM CDK12 EMSY HNF1A MPL PALB2 SF3B1 VHL
ATR CDK2 ERBB2 HRAS MRE11A PARP1 SLCO1B1 WT1
ATRX CDK4 ERBB3 IDH1 MSH2 PARP2 SMAD4
AURKA CDK5 ERBB4 IDH2 MSH6 PDGFRA SMARCB1
AURKB CDK6 ERCC2 IGF1R MTOR PIK3CA SMO
AXL CDK8 ESR1 JAK2 MUTYH PMS2 SRC
BCL2 CDK9 ETV6 JAK3 MYC PTCH1 SRSF2
BRAF CDKN2A EZH2 KDR MYD88 PTEN STK11
+ Breast Cancer Genes
ABL1 BRCA1 CDKN2B FGFR1 KIT NBN PTPN11 SYK
ABL2 BRCA2 CEBPA FGFR2 KRAS NF1 RAD50 TET2
AKT1 BTK CSF1R FGFR3 MAP2K1 NFE2L2 RB1 TP53
AKT3 CALR CTNNB1 FGFR4 MAP2K2 NOTCH1 RET TPMT
ALK CCND1 CYP2D6 FLT3 MAPK1 NPM1 RICTOR TSC1
APC CCND2 DDR2 GNA11 MCL1 NRAS RNF43 TSC2
AR CCND3 DNMT3A GNAQ MDM2 NTRK1 ROS1 U2AF1
ARAF CD274 DPYD GNAS MET NTRK2 RPTOR UGT1A1
ASXL1 CDH1 EGFR H3F3A MLH1 NTRK3 RUNX1 VEGFA
ATM CDK12 EMSY HNF1A MPL PALB2 SF3B1 VHL
ATR CDK2 ERBB2 HRAS MRE11A PARP1 SLCO1B1 WT1
ATRX CDK4 ERBB3 IDH1 MSH2 PARP2 SMAD4
AURKA CDK5 ERBB4 IDH2 MSH6 PDGFRA SMARCB1
AURKB CDK6 ERCC2 IGF1R MTOR PIK3CA SMO
AXL CDK8 ESR1 JAK2 MUTYH PMS2 SRC
BCL2 CDK9 ETV6 JAK3 MYC PTCH1 SRSF2
BRAF CDKN2A EZH2 KDR MYD88 PTEN STK11
+ Lung Cancer Genes
ABL1 BRCA1 CDKN2B FGFR1 KIT NBN PTPN11 SYK
ABL2 BRCA2 CEBPA FGFR2 KRAS NF1 RAD50 TET2
AKT1 BTK CSF1R FGFR3 MAP2K1 NFE2L2 RB1 TP53
AKT3 CALR CTNNB1 FGFR4 MAP2K2 NOTCH1 RET TPMT
ALK CCND1 CYP2D6 FLT3 MAPK1 NPM1 RICTOR TSC1
APC CCND2 DDR2 GNA11 MCL1 NRAS RNF43 TSC2
AR CCND3 DNMT3A GNAQ MDM2 NTRK1 ROS1 U2AF1
ARAF CD274 DPYD GNAS MET NTRK2 RPTOR UGT1A1
ASXL1 CDH1 EGFR H3F3A MLH1 NTRK3 RUNX1 VEGFA
ATM CDK12 EMSY HNF1A MPL PALB2 SF3B1 VHL
ATR CDK2 ERBB2 HRAS MRE11A PARP1 SLCO1B1 WT1
ATRX CDK4 ERBB3 IDH1 MSH2 PARP2 SMAD4
AURKA CDK5 ERBB4 IDH2 MSH6 PDGFRA SMARCB1
AURKB CDK6 ERCC2 IGF1R MTOR PIK3CA SMO
AXL CDK8 ESR1 JAK2 MUTYH PMS2 SRC
BCL2 CDK9 ETV6 JAK3 MYC PTCH1 SRSF2
BRAF CDKN2A EZH2 KDR MYD88 PTEN STK11
+ Ovarian Cancer Genes
ABL1 BRCA1 CDKN2B FGFR1 KIT NBN PTPN11 SYK
ABL2 BRCA2 CEBPA FGFR2 KRAS NF1 RAD50 TET2
AKT1 BTK CSF1R FGFR3 MAP2K1 NFE2L2 RB1 TP53
AKT3 CALR CTNNB1 FGFR4 MAP2K2 NOTCH1 RET TPMT
ALK CCND1 CYP2D6 FLT3 MAPK1 NPM1 RICTOR TSC1
APC CCND2 DDR2 GNA11 MCL1 NRAS RNF43 TSC2
AR CCND3 DNMT3A GNAQ MDM2 NTRK1 ROS1 U2AF1
ARAF CD274 DPYD GNAS MET NTRK2 RPTOR UGT1A1
ASXL1 CDH1 EGFR H3F3A MLH1 NTRK3 RUNX1 VEGFA
ATM CDK12 EMSY HNF1A MPL PALB2 SF3B1 VHL
ATR CDK2 ERBB2 HRAS MRE11A PARP1 SLCO1B1 WT1
ATRX CDK4 ERBB3 IDH1 MSH2 PARP2 SMAD4
AURKA CDK5 ERBB4 IDH2 MSH6 PDGFRA SMARCB1
AURKB CDK6 ERCC2 IGF1R MTOR PIK3CA SMO
AXL CDK8 ESR1 JAK2 MUTYH PMS2 SRC
BCL2 CDK9 ETV6 JAK3 MYC PTCH1 SRSF2
BRAF CDKN2A EZH2 KDR MYD88 PTEN STK11

The TOMA SIGNOMETM Tumor Profiling System is a highly efficient comprehensive solution to generate rich tumor profiling data.

Powered by TOMA OS-SeqTM, the target enrichment is complete in less than two hours to enable detection of variants down to a 2% variant allele frequency (VAF).

SIGNOMETM offers a fast, simple approach to generating reliable sequencing data.

TOMA’s cloud based data analysis tools:

Simple - Complete - Meaningful

STRATUS

Upload
Authenticate
Encrypted Transport
Encryption at Rest
Start Workflow

SIGNOMETM

Analyze
Proprietary Algorithms
Map Reads
Identify & Score Variants, CNAs
Output: Interpretable Somatic Alternations

SEQUENCING PERFORMANCE METRICS

6 CONCURRENT SAMPLES ON ILLUMINA MISEQ

Mean Coverage On - Target Fold Enrichment Fold 80 Base Penalty % ROI Bases 2X % ROI Bases 50X % ROI Bases 100X
> 500 X 50-80% 1200-2300 1.9 - 3.5 99.5% 98.5% 98.1%