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
SIGNOMETMOTHER COMMERCIAL REAGENTSTOMA OS-SEQTM ADVANTAGE
CANCER GENE COVERAGEComprehensive – complete sequencing of every exon interrogatedLimited – “Hot Spot” methods exclude up to 90% of each gene and are not able to report all variant typesDetects all mutation types: single nucleotide variations, short indels, and copy number alterations
SAMPLE - EFFICIENTHigh – 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 QNSPreserve precious patient sample – DNA inputs as low as 10ng and reduce samples rejected due to "quantity not sufficient" QNS
SENSITIVE VARIANT DETECTIONComplete – 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 cancerDramatically increases clinically significant findings
EFFICIENCYHigh Yield – from ultra efficient adaptor ligationLow Yield – highly dependant upon PCR to generate sufficient library for sequencingHighly efficient library preparation method preserves precious sample
PCR USED IN DNA PREPARATIONMinimal – library preparation method only amplifies targets of interest; eliminates whole genome PCRHigh – amplifies “whole genome” PCR creating artifacts and errors, reducing specificity and causing analysis issuesNo “whole genome,” PCR dramatically reduces errors common to other methods
SEQUENCING DEPTH500X – up to 6 concurrent samples on an Illumina MiSeqLOW – misses key mutations and increases false negativesMinimizes false negatives
ANALYSISSimple – TOMA Stratus™ easy, accurate calling of somatic alterations, including CNAsNone – limited assay specific bioinformatics; not designed for somatic alteration detectionSimple – Stratus provides the easiest, high accuracy variant calls including copy number
TIMINGFast – DNA library complete in 16 hours (3 hrs hands on time)Slow – takes 2-3 daysGenerates a sequencing library in a single day

TOMA OS-SEQTM 130 CANCER GENE PANEL

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

ABL1BRCA1CDKN2BFGFR1KITNBNPTPN11SYK
ABL2BRCA2CEBPAFGFR2KRASNF1RAD50TET2
AKT1BTKCSF1RFGFR3MAP2K1NFE2L2RB1TP53
AKT3CALRCTNNB1FGFR4MAP2K2NOTCH1RETTPMT
ALKCCND1CYP2D6FLT3MAPK1NPM1RICTORTSC1
APCCCND2DDR2GNA11MCL1NRASRNF43TSC2
ARCCND3DNMT3AGNAQMDM2NTRK1ROS1U2AF1
ARAFCD274DPYDGNASMETNTRK2RPTORUGT1A1
ASXL1CDH1EGFRH3F3AMLH1NTRK3RUNX1VEGFA
ATMCDK12EMSYHNF1AMPLPALB2SF3B1VHL
ATRCDK2ERBB2HRASMRE11APARP1SLCO1B1WT1
ATRXCDK4ERBB3IDH1MSH2PARP2SMAD4
AURKACDK5ERBB4IDH2MSH6PDGFRASMARCB1
AURKBCDK6ERCC2IGF1RMTORPIK3CASMO
AXLCDK8ESR1JAK2MUTYHPMS2SRC
BCL2CDK9ETV6JAK3MYCPTCH1SRSF2
BRAFCDKN2AEZH2KDRMYD88PTENSTK11
ABL1BRCA1CDKN2BFGFR1KITNBNPTPN11SYK
ABL2BRCA2CEBPAFGFR2KRASNF1RAD50TET2
AKT1BTKCSF1RFGFR3MAP2K1NFE2L2RB1TP53
AKT3CALRCTNNB1FGFR4MAP2K2NOTCH1RETTPMT
ALKCCND1CYP2D6FLT3MAPK1NPM1RICTORTSC1
APCCCND2DDR2GNA11MCL1NRASRNF43TSC2
ARCCND3DNMT3AGNAQMDM2NTRK1ROS1U2AF1
ARAFCD274DPYDGNASMETNTRK2RPTORUGT1A1
ASXL1CDH1EGFRH3F3AMLH1NTRK3RUNX1VEGFA
ATMCDK12EMSYHNF1AMPLPALB2SF3B1VHL
ATRCDK2ERBB2HRASMRE11APARP1SLCO1B1WT1
ATRXCDK4ERBB3IDH1MSH2PARP2SMAD4
AURKACDK5ERBB4IDH2MSH6PDGFRASMARCB1
AURKBCDK6ERCC2IGF1RMTORPIK3CASMO
AXLCDK8ESR1JAK2MUTYHPMS2SRC
BCL2CDK9ETV6JAK3MYCPTCH1SRSF2
BRAFCDKN2AEZH2KDRMYD88PTENSTK11
ABL1BRCA1CDKN2BFGFR1KITNBNPTPN11SYK
ABL2BRCA2CEBPAFGFR2KRASNF1RAD50TET2
AKT1BTKCSF1RFGFR3MAP2K1NFE2L2RB1TP53
AKT3CALRCTNNB1FGFR4MAP2K2NOTCH1RETTPMT
ALKCCND1CYP2D6FLT3MAPK1NPM1RICTORTSC1
APCCCND2DDR2GNA11MCL1NRASRNF43TSC2
ARCCND3DNMT3AGNAQMDM2NTRK1ROS1U2AF1
ARAFCD274DPYDGNASMETNTRK2RPTORUGT1A1
ASXL1CDH1EGFRH3F3AMLH1NTRK3RUNX1VEGFA
ATMCDK12EMSYHNF1AMPLPALB2SF3B1VHL
ATRCDK2ERBB2HRASMRE11APARP1SLCO1B1WT1
ATRXCDK4ERBB3IDH1MSH2PARP2SMAD4
AURKACDK5ERBB4IDH2MSH6PDGFRASMARCB1
AURKBCDK6ERCC2IGF1RMTORPIK3CASMO
AXLCDK8ESR1JAK2MUTYHPMS2SRC
BCL2CDK9ETV6JAK3MYCPTCH1SRSF2
BRAFCDKN2AEZH2KDRMYD88PTENSTK11
ABL1BRCA1CDKN2BFGFR1KITNBNPTPN11SYK
ABL2BRCA2CEBPAFGFR2KRASNF1RAD50TET2
AKT1BTKCSF1RFGFR3MAP2K1NFE2L2RB1TP53
AKT3CALRCTNNB1FGFR4MAP2K2NOTCH1RETTPMT
ALKCCND1CYP2D6FLT3MAPK1NPM1RICTORTSC1
APCCCND2DDR2GNA11MCL1NRASRNF43TSC2
ARCCND3DNMT3AGNAQMDM2NTRK1ROS1U2AF1
ARAFCD274DPYDGNASMETNTRK2RPTORUGT1A1
ASXL1CDH1EGFRH3F3AMLH1NTRK3RUNX1VEGFA
ATMCDK12EMSYHNF1AMPLPALB2SF3B1VHL
ATRCDK2ERBB2HRASMRE11APARP1SLCO1B1WT1
ATRXCDK4ERBB3IDH1MSH2PARP2SMAD4
AURKACDK5ERBB4IDH2MSH6PDGFRASMARCB1
AURKBCDK6ERCC2IGF1RMTORPIK3CASMO
AXLCDK8ESR1JAK2MUTYHPMS2SRC
BCL2CDK9ETV6JAK3MYCPTCH1SRSF2
BRAFCDKN2AEZH2KDRMYD88PTENSTK11
+ 130 Gene Cancer Panel
ABL1BRCA1CDKN2BFGFR1KITNBNPTPN11SYK
ABL2BRCA2CEBPAFGFR2KRASNF1RAD50TET2
AKT1BTKCSF1RFGFR3MAP2K1NFE2L2RB1TP53
AKT3CALRCTNNB1FGFR4MAP2K2NOTCH1RETTPMT
ALKCCND1CYP2D6FLT3MAPK1NPM1RICTORTSC1
APCCCND2DDR2GNA11MCL1NRASRNF43TSC2
ARCCND3DNMT3AGNAQMDM2NTRK1ROS1U2AF1
ARAFCD274DPYDGNASMETNTRK2RPTORUGT1A1
ASXL1CDH1EGFRH3F3AMLH1NTRK3RUNX1VEGFA
ATMCDK12EMSYHNF1AMPLPALB2SF3B1VHL
ATRCDK2ERBB2HRASMRE11APARP1SLCO1B1WT1
ATRXCDK4ERBB3IDH1MSH2PARP2SMAD4
AURKACDK5ERBB4IDH2MSH6PDGFRASMARCB1
AURKBCDK6ERCC2IGF1RMTORPIK3CASMO
AXLCDK8ESR1JAK2MUTYHPMS2SRC
BCL2CDK9ETV6JAK3MYCPTCH1SRSF2
BRAFCDKN2AEZH2KDRMYD88PTENSTK11
+ Breast Cancer Genes
ABL1BRCA1CDKN2BFGFR1KITNBNPTPN11SYK
ABL2BRCA2CEBPAFGFR2KRASNF1RAD50TET2
AKT1BTKCSF1RFGFR3MAP2K1NFE2L2RB1TP53
AKT3CALRCTNNB1FGFR4MAP2K2NOTCH1RETTPMT
ALKCCND1CYP2D6FLT3MAPK1NPM1RICTORTSC1
APCCCND2DDR2GNA11MCL1NRASRNF43TSC2
ARCCND3DNMT3AGNAQMDM2NTRK1ROS1U2AF1
ARAFCD274DPYDGNASMETNTRK2RPTORUGT1A1
ASXL1CDH1EGFRH3F3AMLH1NTRK3RUNX1VEGFA
ATMCDK12EMSYHNF1AMPLPALB2SF3B1VHL
ATRCDK2ERBB2HRASMRE11APARP1SLCO1B1WT1
ATRXCDK4ERBB3IDH1MSH2PARP2SMAD4
AURKACDK5ERBB4IDH2MSH6PDGFRASMARCB1
AURKBCDK6ERCC2IGF1RMTORPIK3CASMO
AXLCDK8ESR1JAK2MUTYHPMS2SRC
BCL2CDK9ETV6JAK3MYCPTCH1SRSF2
BRAFCDKN2AEZH2KDRMYD88PTENSTK11
+ Lung Cancer Genes
ABL1BRCA1CDKN2BFGFR1KITNBNPTPN11SYK
ABL2BRCA2CEBPAFGFR2KRASNF1RAD50TET2
AKT1BTKCSF1RFGFR3MAP2K1NFE2L2RB1TP53
AKT3CALRCTNNB1FGFR4MAP2K2NOTCH1RETTPMT
ALKCCND1CYP2D6FLT3MAPK1NPM1RICTORTSC1
APCCCND2DDR2GNA11MCL1NRASRNF43TSC2
ARCCND3DNMT3AGNAQMDM2NTRK1ROS1U2AF1
ARAFCD274DPYDGNASMETNTRK2RPTORUGT1A1
ASXL1CDH1EGFRH3F3AMLH1NTRK3RUNX1VEGFA
ATMCDK12EMSYHNF1AMPLPALB2SF3B1VHL
ATRCDK2ERBB2HRASMRE11APARP1SLCO1B1WT1
ATRXCDK4ERBB3IDH1MSH2PARP2SMAD4
AURKACDK5ERBB4IDH2MSH6PDGFRASMARCB1
AURKBCDK6ERCC2IGF1RMTORPIK3CASMO
AXLCDK8ESR1JAK2MUTYHPMS2SRC
BCL2CDK9ETV6JAK3MYCPTCH1SRSF2
BRAFCDKN2AEZH2KDRMYD88PTENSTK11
+ Ovarian Cancer Genes
ABL1BRCA1CDKN2BFGFR1KITNBNPTPN11SYK
ABL2BRCA2CEBPAFGFR2KRASNF1RAD50TET2
AKT1BTKCSF1RFGFR3MAP2K1NFE2L2RB1TP53
AKT3CALRCTNNB1FGFR4MAP2K2NOTCH1RETTPMT
ALKCCND1CYP2D6FLT3MAPK1NPM1RICTORTSC1
APCCCND2DDR2GNA11MCL1NRASRNF43TSC2
ARCCND3DNMT3AGNAQMDM2NTRK1ROS1U2AF1
ARAFCD274DPYDGNASMETNTRK2RPTORUGT1A1
ASXL1CDH1EGFRH3F3AMLH1NTRK3RUNX1VEGFA
ATMCDK12EMSYHNF1AMPLPALB2SF3B1VHL
ATRCDK2ERBB2HRASMRE11APARP1SLCO1B1WT1
ATRXCDK4ERBB3IDH1MSH2PARP2SMAD4
AURKACDK5ERBB4IDH2MSH6PDGFRASMARCB1
AURKBCDK6ERCC2IGF1RMTORPIK3CASMO
AXLCDK8ESR1JAK2MUTYHPMS2SRC
BCL2CDK9ETV6JAK3MYCPTCH1SRSF2
BRAFCDKN2AEZH2KDRMYD88PTENSTK11

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

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SIGNOMETM

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

SEQUENCING PERFORMANCE METRICS

6 CONCURRENT SAMPLES ON ILLUMINA MISEQ

Mean CoverageOn - TargetFold EnrichmentFold 80 Base Penalty% ROI Bases 2X% ROI Bases 50X% ROI Bases 100X
> 500 X50-80%1200-23001.9 - 3.599.5%98.5%98.1%