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At a glance
Genes assessed
•	 Sequence variation assessed in 223 cancer, DNA repair & pharmacogenomic genes
•	 Total target bases: 1.328 megabases
•	 206 genes assessed for coding sequence variation
•	 9 genes assessed for coding sequence and genomic rearrangements
•	 8 genes assessed for genomic rearrangements
Technology platforms •	 Sequenced on Illumina sequencing platforms
Analytical
specifications
•	 Analytically validated to CLIA standards
•	 Sensitivity (SNVs/InDels): > 99% for SNVs present at ≥ 5% allele frequency,
> 99% for indels present at ≥ 10% allele frequency
•	 Specificity: > 99% for SNVs and indels present at ≥ 5% allele frequency
•	 Limit of detection: 4% for SNVs, 10% for indels
Genomics technology is transforming oncology treatment and drug development. The tools are now
available to better understand the relationship between biomarkers and patient responses.
Quintiles has developed the Quintiles Comprehensive Cancer Panel (QCCP), a targeted sequencing
assay for simultaneous analysis of genomic variation which may be predictive of response to multiple
therapies in clinical development.
Improve your probability of success with the QCCP
•	 Detects the most common actionable somatic alterations currently reported in cancer, including: point mutations, insertions,
deletions and structural rearrangements
•	 Identifies pathways, markers of disease and unique variant types to select for patient populations likely to benefit from
targeted therapies.
•	 Better predicts safety and efficacy based on a tumor’s genetic make up
Targeted genomic sequencing assay
for comprehensive molecular characterization of tumor specimens
Technical specifications
Designed for both discovery and clinical applications, the QCCP – analytically validated CLIA standards – provides insight into
most pathways associated with cancers.
With over 90 publications, FDA collaborations and participation in
standardization initiatives, EA|Quintiles continues its market position as a
leading provider of genomics services in clinical trials and research.
Copyright©2015Quintiles.Allrightsreserved.02.0015-1-02.15
Contact us
Toll free: 1 866 293 6094	
Direct: +1 919 405 2248
Website: www.expressionanalysis.com	
Email: clinical@quintiles.com
Unmatched genomic and bioinformatics expertise
Together, Expression Analysis (EA|Quintiles) and Quintiles
provide comprehensive genomic technologies and valuable
insight across the entire continuum of drug development.
•	 Unmatched experience in development of custom
sequencing assays
•	 A variety of preconfigured CLIA LDTs
•	 Bioinformatics staff includes PhD-level scientists drawn
from computer science, statistics and biology
•	 Other assays such as QPCR, RT-PCR, FISH, IHC, or 3rd
generation sequencing also available
•	 Biological Pathway Analysis and Cohort Analysis
•	 Novella Clinical Research, a Quintiles Company, provides
510k and IDE/PMA submissions
Comprehensive cancer panel content
The 223 gene cancer panel includes the genes most commonly associated with cancers and can be used to assess mutations,
deletions, insertions and rearrangements.
ABL BLM CRLF2 ETV4 GNAS MAP2K4 NFE2L2 PIK3R5 SF3B1 TP63
ABL2 BRAF CTNNA1 ETV5 GRIN2A MAP3K1 NOTCH1 PMS1 SMAD2 TP73
ACVR1B BRCA1 CTNNB1 ETV6 H3F3A MAPK1 NOTCH2 PMS2 SMAD3 TPMT
AKT1 BRCA2 CYP1A2 EWSR1 HNF1A MDM2 NOTCH3 PPP2R1A SMAD4 TRAF7
AKT2 BTK CYP2C19 EZH2 HRAS MDM4 NOTCH4 PRDM1 SMARCA4 TSC1
AKT3 CARD11 CYP2C9 FAM123B IDH1 MED12 NPM1 PTCH1 SMARCB1 TSC2
ALK CASP8 CYP2D6 FANCA IDH2 MEN1 NRAS PTCH2 SMO TSHR
APC CBL DAXX FBXW7 IGF1R MET NTRK1 PTEN SOCS1 TYMS
AR CCND1 DDR2 FGFR1 IGF2R MITF NTRK2 PTPN11 SRC U2AF1
ARAF CCND2 DNMT3A FGFR2 IKZF1 MLH1 NTRK3 RAD50 SRSF2 UGT1A1
ARID1A CCND3 DPYD FGFR3 IL7R MLL PALB2 RAD51 STAG2 VHL
ARID1B CCNE1 EGFR FGFR4 INSR MPL PARP1 RAF1 STAT1 VKORC1
ASXL1 CDC73 EP300 FLT1 JAK1 MRE11A PAX5 RARA STAT3 WRN
ATM CDH1 ERBB2 FLT3 JAK2 MSH2 PBRM1 RB1 STK11 WT1
ATR CDK4 ERBB3 FLT4 JAK3 MSH6 PDGFRA RET SUFU XPC
ATRX CDK6 ERBB4 FOXL2 KDM6A MTHFR PDGFRB RICTOR TERT XRCC1
AURKA CDKN2A ERCC1 G6PD KDR MTOR PDK1 RNF43 TET2
AURKB CDKN2B ERCC2 GATA1 KIT MYC PGR ROS1 TGFBR2
AXIN1 CEBPA ERCC3 GATA2 KLF4 MYCN PHF6 RPTOR TMPRSS2
BAP1 CHEK1 ERG GATA3 KRAS MYD88 PIK3CA RSPO2 TNFAIP3
BCL2 CHEK2 ERRFI1 GLI1 MAML1 NBN PIK3CG RSPO3 TOP1
BCOR CREBBP ESR1 GNA11 MAP2K1 NF1 PIK3R1 RUNX1 TOP2A
BCR CSF1R ETV1 GNAQ MAP2K2 NF2 PIK3R2 SETD2 TP53
Coding Sequence and Rearrangement Assessment (9 genes) Rearrangement Assessment Only (8 genes)
Tumor sample requirements:
Tumor samples should have ≥ 20%
tumor cellularity.
375 ng of tumor DNA
or 50 mg of fresh frozen tumor tissue
or 10 unstained FFPE slides (5-10 µm thick)
Turnaround time:
Standard TAT 3-4 weeks, expedited TAT
available for prospective trials.

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Targeted genomic sequencing assay for comprehensive molecular characterization of tumor specimens

  • 1. At a glance Genes assessed • Sequence variation assessed in 223 cancer, DNA repair & pharmacogenomic genes • Total target bases: 1.328 megabases • 206 genes assessed for coding sequence variation • 9 genes assessed for coding sequence and genomic rearrangements • 8 genes assessed for genomic rearrangements Technology platforms • Sequenced on Illumina sequencing platforms Analytical specifications • Analytically validated to CLIA standards • Sensitivity (SNVs/InDels): > 99% for SNVs present at ≥ 5% allele frequency, > 99% for indels present at ≥ 10% allele frequency • Specificity: > 99% for SNVs and indels present at ≥ 5% allele frequency • Limit of detection: 4% for SNVs, 10% for indels Genomics technology is transforming oncology treatment and drug development. The tools are now available to better understand the relationship between biomarkers and patient responses. Quintiles has developed the Quintiles Comprehensive Cancer Panel (QCCP), a targeted sequencing assay for simultaneous analysis of genomic variation which may be predictive of response to multiple therapies in clinical development. Improve your probability of success with the QCCP • Detects the most common actionable somatic alterations currently reported in cancer, including: point mutations, insertions, deletions and structural rearrangements • Identifies pathways, markers of disease and unique variant types to select for patient populations likely to benefit from targeted therapies. • Better predicts safety and efficacy based on a tumor’s genetic make up Targeted genomic sequencing assay for comprehensive molecular characterization of tumor specimens Technical specifications Designed for both discovery and clinical applications, the QCCP – analytically validated CLIA standards – provides insight into most pathways associated with cancers. With over 90 publications, FDA collaborations and participation in standardization initiatives, EA|Quintiles continues its market position as a leading provider of genomics services in clinical trials and research.
  • 2. Copyright©2015Quintiles.Allrightsreserved.02.0015-1-02.15 Contact us Toll free: 1 866 293 6094 Direct: +1 919 405 2248 Website: www.expressionanalysis.com Email: clinical@quintiles.com Unmatched genomic and bioinformatics expertise Together, Expression Analysis (EA|Quintiles) and Quintiles provide comprehensive genomic technologies and valuable insight across the entire continuum of drug development. • Unmatched experience in development of custom sequencing assays • A variety of preconfigured CLIA LDTs • Bioinformatics staff includes PhD-level scientists drawn from computer science, statistics and biology • Other assays such as QPCR, RT-PCR, FISH, IHC, or 3rd generation sequencing also available • Biological Pathway Analysis and Cohort Analysis • Novella Clinical Research, a Quintiles Company, provides 510k and IDE/PMA submissions Comprehensive cancer panel content The 223 gene cancer panel includes the genes most commonly associated with cancers and can be used to assess mutations, deletions, insertions and rearrangements. ABL BLM CRLF2 ETV4 GNAS MAP2K4 NFE2L2 PIK3R5 SF3B1 TP63 ABL2 BRAF CTNNA1 ETV5 GRIN2A MAP3K1 NOTCH1 PMS1 SMAD2 TP73 ACVR1B BRCA1 CTNNB1 ETV6 H3F3A MAPK1 NOTCH2 PMS2 SMAD3 TPMT AKT1 BRCA2 CYP1A2 EWSR1 HNF1A MDM2 NOTCH3 PPP2R1A SMAD4 TRAF7 AKT2 BTK CYP2C19 EZH2 HRAS MDM4 NOTCH4 PRDM1 SMARCA4 TSC1 AKT3 CARD11 CYP2C9 FAM123B IDH1 MED12 NPM1 PTCH1 SMARCB1 TSC2 ALK CASP8 CYP2D6 FANCA IDH2 MEN1 NRAS PTCH2 SMO TSHR APC CBL DAXX FBXW7 IGF1R MET NTRK1 PTEN SOCS1 TYMS AR CCND1 DDR2 FGFR1 IGF2R MITF NTRK2 PTPN11 SRC U2AF1 ARAF CCND2 DNMT3A FGFR2 IKZF1 MLH1 NTRK3 RAD50 SRSF2 UGT1A1 ARID1A CCND3 DPYD FGFR3 IL7R MLL PALB2 RAD51 STAG2 VHL ARID1B CCNE1 EGFR FGFR4 INSR MPL PARP1 RAF1 STAT1 VKORC1 ASXL1 CDC73 EP300 FLT1 JAK1 MRE11A PAX5 RARA STAT3 WRN ATM CDH1 ERBB2 FLT3 JAK2 MSH2 PBRM1 RB1 STK11 WT1 ATR CDK4 ERBB3 FLT4 JAK3 MSH6 PDGFRA RET SUFU XPC ATRX CDK6 ERBB4 FOXL2 KDM6A MTHFR PDGFRB RICTOR TERT XRCC1 AURKA CDKN2A ERCC1 G6PD KDR MTOR PDK1 RNF43 TET2 AURKB CDKN2B ERCC2 GATA1 KIT MYC PGR ROS1 TGFBR2 AXIN1 CEBPA ERCC3 GATA2 KLF4 MYCN PHF6 RPTOR TMPRSS2 BAP1 CHEK1 ERG GATA3 KRAS MYD88 PIK3CA RSPO2 TNFAIP3 BCL2 CHEK2 ERRFI1 GLI1 MAML1 NBN PIK3CG RSPO3 TOP1 BCOR CREBBP ESR1 GNA11 MAP2K1 NF1 PIK3R1 RUNX1 TOP2A BCR CSF1R ETV1 GNAQ MAP2K2 NF2 PIK3R2 SETD2 TP53 Coding Sequence and Rearrangement Assessment (9 genes) Rearrangement Assessment Only (8 genes) Tumor sample requirements: Tumor samples should have ≥ 20% tumor cellularity. 375 ng of tumor DNA or 50 mg of fresh frozen tumor tissue or 10 unstained FFPE slides (5-10 µm thick) Turnaround time: Standard TAT 3-4 weeks, expedited TAT available for prospective trials.