Covers over 1300+ gene fusionsIdentifies alterations in 500+ cancer-related genesThe AuraSeq-Comprehensive Panel is a highly multiplexed assay based on a next-generation sequencing platform. AuraSeq-Comprehensive identifies clinically relevant alterations in 500 cancer-related genes, including base pair substitutions, small insertions and deletions in thousands of mutational hotspots, as well as copy number variations, intergenic and intragenic fusions, and genomic signatures, allowing physicians to expand treatment options to include most FDA-approved targeted therapies.

Covers over 500 unique genes, to encompass 1.4 Mb of genome, and 1300 gene fusions

Detects single-gene biomarkers such as SNVs, indels, CNVs, fusions, and splice variants (for Molecularly Targeted Therapies)

Detects homologous recombination deficiency (HRD) signatures by assessing variants in 42 HRD genes and genomic instability with sample-level loss of heterozygosity (LOH) in key HRD genes, including BRCA1 and BRCA2 (for PARP inhibitors)

Renders complex multi-gene biomarkers for mutational signatures, including tumor mutational burden (TMB) and microsatellite instability (MSI) (for Immune Checkpoint Inhibitors)

AuraSeq-Comprehensive upholds low QNS rates with high sequencing success rates (>98%) with as little as 2-20 ng of DNA/RNA from FFPE samples1

Highly automated workflow and streamlined bioinformatics analysis pipeline optimized for delivering results with a short turnaround time (TAT = 7-12 days)

TEST DESCRIPTION

The AuraSeq-Comprehensive Panel utilizes next-generation sequencing (NGS) technology to detect cancer-related genomic alterations such as single nucleotide variants (SNVs), small insertions and deletions (Indels), copy number variations (CNVs), and gene fusions; as well as genomic signatures such as tumor mutational burden (TMB), microsatellite instability (MSI), and homologous recombination (HR) repair gene alterations and genomic instability due to HR deficiency (HRD).

This test is intended to detect genomic alterations in several metastatic or advanced cancers, including:

  •  Non-small cell lung cancer (NSCLC) (e.g.: EGFR, BRAF, ERBB2, KRAS, MET (METex14 and METamp), ALK-fusions, ROS1-fusions, RET-fusions). These genomic biomarkers are recommended by national guidelines.

  • Colorectal cancer (CRC) (e.g.: MSI, KRAS, NRAS, BRAF, ROS1-fusions, NTRK1-fusions, NTRK3-fusions). Most of these biomarkers are recommended by national guidelines.

  • Spitzoid melanoma (e.g.: TMB, NTRK1-fusions)

  • Gliomas (e.g.: IDH1, IDH2, EGFRamp, EGFRvIII isoform, 1p/19q co-deletion, NTRK1-fusions, FGFR1-fusions, FGFR3-fusions)

  • Bladder cancer (FGFR3-fusions)

  • Breast cancer (e.g.: BRCA1, BRCA2, HR genes, NTRK3-fusions, FGFR1-fusions, FGFR2-fusions, FGFR3-fusions)

  • Ovarian cancer (e.g.: HRD status, BRCA1, BRCA2, HR genes, NTRK3-fusions, FGFR1-fusions, FGFR2-fusions, and FGFR3-fusions)

  • Prostate cancer (e.g.: HRD status, ERG-fusions, ETV1-fusions, ETV4-fusions, FGFR1-fusions)

  • Pancreatic cancer (e.g.: HRD status, KRAS, SMAD4, NTRK1/2/3-fusions, ROS1-fusions)

  • Soft tissue sarcomas (e.g.: NTRK1-fusions, NTRK3 -fusions)

  • Any other advanced carcinoma which has failed to respond to conventional chemotherapy or is about to start tyrosine kinase inhibitors (TKIs), an immune checkpoint inhibitor (ICI) or a poly (ADP ribose) polymerase (PARP) inhibitor regime.

The detection of cancer-related SNVs, small Indels, and structural variants (SVs), including CNVs and gene fusions using NGS technology in solid tumors, has shown great clinical utility by providing informative genomic data to assist health care providers in making a diagnosis of cancer, estimating prognosis, and making treatment decisions involving molecular targeted drugs.2, 3 As new molecular targeted therapies become available in clinical practice, detection of targetable gene variants as well as genomic signatures is increasingly important in order to drive therapy of choice.

The AuraSeq Impact 

Variant Types Detected 

Validated for Small Samples - AuraSeq requires minimal material, with cytology smears being acceptable.4, 5

Great Success Rate - With a <2% QNS rate6, lower than other leading NGS-based test providers, including samples with low tumor content (5-10% neoplastic nuclei).7

Actionable Results for Oncology - Provides information on targets of >85 FDA-approved therapies, and clinical trial eligibility. 

 

TAT 7-12 days
Sample Type

FFPE; Cytology Smears 

DNA Input

2-20 ng

RNA Input

2-20 ng 

Failure Rate

5.6%5 

No. of Genes

500+, 1,300 fusions 

LoD

4%

 

The AuraSeq-Comprehensive test assesses both DNA and RNA for a uniquely comprehensive and highly accurate detection of actionable biomarkers for solid tumor cancers utilizing very limited tissue or cytology smears. 

 

Genes & Fusions

> 500 genes +

> 1300 fusions 

DNA  
RNA  
Hotspots (SNVs + Indels)  
CNVs  
Fusions  
MSI  
TMB  
HRD  
Long Indels   
ABL1 CUL1 HIST1H2BD NFE2L2 RICTOR
ABL2 CYSLTR2 HIST1H3B NRAS RIT1
ACVR1 DDR2 HRAS NSD2 ROS1
AKT1 DGCR8 IDH1 NT5C2 RPL10
AKT2 DROSHA IDH2 NTRK1 SETBP1
AKT3 E2F1 IKBKB NTRK2 SF3B1
ALK EGFR IL6ST NTRK3 SIX1
AR EIF1AX IL7R NUP93 SIX2
ARAF EPAS1 IRF4 PAX5 SLCO1B3
ATP1A1 ERBB2 IRS4 PCBP1 SMC1A
AURKA ERBB3 KDR PDGFRA SMO
AURKC ERBB4 KIT PDGFRB SNCAIP
AXL ESR1 KLF4 PIK3C2B SOS1
BCL2 EZH2 KLF5 PIK3CA SOX2
BCL2L12 FAM135B KNSTRN PIK3CB SPOP
BCL6 FGF7 KRAS PIK3CD SRC
BCR FGFR1 MAGOH PIK3CG SRSF2
BMP5 FGFR2 MAP2K1 PIK3R2 STAT3
BRAF FGFR3 MAP2K2 PIM1 STAT5B
BTK FGFR4 MAPK1 PLCG1 STAT6
CACNA1D FLT3 MAX PPP2R1A TAF1
CARD11 FLT4 MDM4 PPP6C TERT
CBL FOXA1 MECOM PRKACA TGFBR1
CCND1 FOXL2 MED12 PTPN11 TOP1
CCND2 FOXO1 MEF2B PTPRD TPMT
CCND3 GATA2 MET PXDNL TRRAP
CCNE1 GLI1 MITF RAC1 TSHR
CD79B GNA11 MPL RAF1 U2AF1
CDK4 GNAQ MTOR RARA USP8
CDK6 GNAS MYC RET WAS
CHD4 H3F3A MYCN RGS7 XPO1
CSF1R H3F3B MYD88 RHEB ZNF217
CTNNB1 HIF1A MYOD1 RHOA ZNF429

 

ABCB1 CHEK2 GATA2 NBN RHEB
ABL1 CIC GATA3 NCOR1 RICTOR
ABL2 CREBBP GLI3 NF1 RIT1
ABRAXAS1 CSMD3 GNA13 NF2 RNASEH2A
ACVR1B CTCF GNAS NFE2L2 RNASEH2B
ACVR2A CTLA4 GPS2 NOTCH1 RNF43
ADAMTS12 CTNND2 H3F3A NOTCH2 ROS1
ADAMTS2 CUL3 H3F3B NOTCH3 RPA1
AKT1 CUL4A HDAC2 NOTCH4 RPS6KB1
AKT2 CUL4B HDAC9 NRAS RPTOR
AKT3 CYLD HLA-A NTRK1 RUNX1
ALK CYP2C9 HLA-B NTRK3 SDHA
AMER1 DAXX HNF1A PALB2 SDHB
APC DDR1 IDH2 PARP1 SDHD
AR DDR2 IGF1R PARP2 SETBP1
ARAF DDX3X IKBKB PARP3 SETD2
ARHGAP35 DICER1 IL7R PARP4 SF3B1
ARID1A DNMT3A INPP4B PBRM1 SLCO1B3
ARID1B DOCK3 JAK1 PCBP1 SLX4
ARID2 DPYD JAK2 PDCD1 SMAD2
ARID5B DSC1 JAK3 PDCD1LG2 SMAD4
ASXL1 DSC3 KDM5C PDGFRA SMARCA4
ASXL2 EGFR KDM6A PDGFRB SMARCB1
ATM EIF1AX KDR PDIA3 SMC1A
ATR ELF3 KEAP1 PGD SMO
ATRX EMSY KIT PHF6 SOX9
AURKA ENO1 KLF5 PIK3C2B SPEN
AURKC EP300 KMT2A PIK3CA SPOP
AXIN1 EPCAM KMT2B PIK3CB SRC
AXIN2 EPHA2 KMT2C PIK3R1 STAG2
AXL ERAP1 KMT2D PIK3R2 STAT3
B2M ERAP2 KRAS PIM1 STAT6
BAP1 ERBB2 LARP4B PLCG1 STK11
BARD1 ERBB3 LATS1 PMS1 SUFU
BCL2 ERBB4 LATS2 PMS2 TAP1
BCL2L12 ERCC2 MAGOH POLD1 TAP2
BCL6 ERCC4 MAP2K1 POLE TBX3
BCOR ERRFI1 MAP2K4 POT1 TCF7L2
BLM ESR1 MAP2K7 PPM1D TERT
BMPR2 ETV6 MAP3K1 PPP2R1A TET2
BRAF EZH2 MAP3K4 PPP2R2A TGFBR2
BRCA1 FAM135B MAPK1 PPP6C TNFAIP3
BRCA2 FANCA MAPK8 PRDM1 TNFRSF14
BRIP1 FANCC MAX PRDM9 TOP1
CARD11 FANCD2 MCL1 PRKACA TP53
CASP8 FANCE MDM2 PRKAR1A TP63
CBFB FANCF MDM4 PTCH1 TPMT
CBL FANCG MECOM PTEN TPP2
CCND1 FANCI MEF2B PTPN11 TSC1
CCND2 FANCL MEN1 PTPRT TSC2
CCND3 FANCM MET PXDNL U2AF1
CCNE1 FAT1 MGA RAC1 USP8
CD274 FBXW7 MITF RAD50 USP9X
CD276 FGF19 MLH1 RAD51 VHL
CDC73 FGF23 MLH3 RAD51B WT1
CDH1 FGF3 MPL RAD51C XPO1
CDH10 FGF4 MRE11 RAD51D XRCC2
CDK12 FGF9 MSH2 RAD52 XRCC3
CDK4 FGFR1 MSH3 RAD54L YAP1
CDK6 FGFR2 MSH6 RAF1 YES1
CDKN1A FGFR3 MTAP RARA ZFHX3
CDKN1B FGFR4 MTOR RASA1 ZMYM3
CDKN2A FLT3 MUTYH RASA2 ZNF217
CDKN2B FLT4 MYC RB1 ZNF429
CDKN2C FOXA1 MYCL RBM10 ZRSR2
CHD4 FUBP1 MYCN RECQL4  
CHEK1 FYN MYD88 RET  
AKT2 ERG KRAS NTRK3 RB1
ALK ESR1 MDM4 NUTM1 RELA
AR ETV1 MET PDGFRA RET
AXL ETV4 MYB PDGFRB ROS1
BRAF ETV5 MYBL1 PIK3CA RSPO2
BRCA1 FGFR1 NF1 PPARG RSPO3
BRCA2 FGFR2 NOTCH1 PRKACA TERT
CDKN2A FGFR3 NOTCH4 PRKACB  
EGFR FGR NRG1 PTEN  
ERBB2 FLT3 NTRK1 RAD51B  
ERBB4 JAK2 NTRK2 RAF1  

Bold and Italics = HRR Genes

ABRAXAS1

CREBBP HDAC2 PARP1 RUNX1

ACVR1B

CSMD3 HDAC9 PARP2 RUNX1T1

ACVR2A

CTCF HLA-A PARP3 SDHA

ADAMTS12

CTLA4 HLA-B PARP4 SDHB

ADAMTS2

CUL3 HNF1A PBRM1 SDHC

AMER1

CUL4A ID3 PDCD1 SDHD

APC

CUL4B INPP4B PDCD1LG2 SETD2

ARHGAP35

CYLD JAK1 PDIA3 SLX4

ARID1A

CYP2C9 JAK2 PGD SMAD2

ARID1B

CYP2D6 JAK3 PHF6 SMAD4

ARID2

DAXX KDM5C PIK3R1 SMARCA4

ARID5B

DDX3X KDM6A PMS1 SMARCB1

ASXL1

DICER1 KEAP1 PMS2 SOCS1

ASXL2

DNMT3A KLHL13 POLD1 SOX9

ATM

DOCK3 KMT2A POLE SPEN

ATR

DPYD KMT2B POT1 STAG2

ATRX

DSC1 KMT2C PPM1D STAT1

AXIN1

DSC3 KMT2D PPP2R2A STK11

AXIN2

ELF3 LARP4B PRDM1 SUFU

B2M

ENO1 LATS1 PRDM9 TAP1

BAP1

EP300 LATS2 PRKAR1A TAP2

 BARD1

EPCAM MAP2K4 PSMB10 TBX3

BCOR

EPHA2 MAP2K7 PSMB8 TCF7L2

BLM

ERAP1 MAP3K1 PSMB9 TET2

BMPR2

ERAP2 MAP3K4 PTCH1 TGFBR2

BRCA1

ERCC2 MAPK8 PTEN TMEM132D

BRCA2 

ERCC4 MEN1 PTPRT TNFAIP3

BRIP1 

ERCC5 MGA RAD50 TNFRSF14

CALR

ERRFI1 MLH1 RAD51 TP53

CASP8

ETV6 MLH3 RAD51B TP63

CBFB

FANCA MRE11 RAD51C TPP2

CD274

FANCC MSH2 RAD51D TSC1

CD276

FANCD2 MSH3 RAD52 TSC2

CDC73

FANCE MSH6 RAD54L UGT1A1

CDH1

FANCF MTAP RASA1 USP9X

CDH10

FANCG MTUS2 RASA2 VHL

CDK12 

FANCI MUTYH RB1 WT1

CDKN1A

FANCL NBN RBM10 XRCC2

CDKN1B

FANCM NCOR1 RECQL4 XRCC3

CDKN2A

FAS NF1 RNASEH2A ZBTB20

CDKN2B

FAT1 NF2 RNASEH2B ZFHX3

CDKN2C

FBXW7 NOTCH1 RNASEH2C ZMYM3

CHEK1 

FUBP1 NOTCH2 RNF43 ZRSR2

CHEK2 

GATA3 NOTCH3 RPA1  

CIC

GNA13 NOTCH4 RPL22  

CIITA

GPS2 PALB2 RPL5  

TEST ORDERING

The intended use of the AuraSeq-Comprehensive test is to detect somatic variants in multiple cancer driver genes and genomic signatures using NGS technology in advanced carcinoma samples to help guide therapeutic decisions, especially in those patients who have failed to respond to conventional chemotherapy or are about to start a TKI regime, Immune Checkpoint Inhibition (ICI), or PARP inhibitors (PARPi) therapies.

Physicians (or other individuals authorized by law to order tests) should only order tests that are medically necessary for the diagnosis or treatment of the patient.

Test Ordering

 

Request shipping kits or requisitions:

AuraSeq@sonichealthcareusa.com

or 904.296.2333 

Ship materials to: 

Bernhardt Laboratories 

Attn: Molecular Department 

3728 Philips Highway, Suite 64 

Jacksonville, FL 32207

 

Specimen Requirements

  • Compatible with formalin-fixed, paraffin-embedded (FFPE) tissue samples
  • 1 H&E + 4-5 unstained/unbaked slides
  • Compatible with cytology smears (1-2 slides)
  • Requires minimal nucleic acid input (2 to 20 ng total of DNA and/or RNA)

Reporting

  • All relevant findings are summarized in the first page 
  • Relevant non-NGS findings such as MMR and PD-L1 by IHC are also listed in the report (when applicable) 

References:

1 Data on ~2300 samples submitted for AuraSeq testing.

2 Nature. 2018;553(7689):446-454.

3 JAMA. 2021;325(7):669-685.

4 Cancer Cytopathol. 2019;127(5):285-296.

5 J Clin Pathol. 2021;207825.

6 Data on ~2300 samples submitted for AuraSeq testing.

7 J Oncol Pract. 2016;12(4):e396-404.

This test was developed and its performance characteristics determined by Sonic Healthcare USA, Anatomic Pathology and Bernhardt Laboratories. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes and should not be regarded as investigational or for research. Bernhardt Laboratories is qualified to perform high complexity testing under the Clinical Laboratory Improvement Amendments (CLIA). This test is considered an LDT- Laboratory Developed Test.

Copyright © 2022 Sonic Healthcare USA, Inc. All rights reserved. All of the information in this document is the property of Sonic Healthcare USA. It may not be distributed, transmitted, reproduced, copied or displayed without the written permission of Sonic Healthcare USA. Sonic Healthcare USA, including its affiliates, does not dispense medical advice. The content in this marketing collateral is intended for informational purposes only and does not constitute legal, medical or any professional advice.

Auraseq Comprehensive samples can not be recieved by the states of New York or California.