NGS in Cancer Pathology After the Microscope: From Nucleic Acid to Interpretation

Similar documents
AVENIO family of NGS oncology assays ctdna and Tumor Tissue Analysis Kits

AVENIO ctdna Analysis Kits The complete NGS liquid biopsy solution EMPOWER YOUR LAB

NGS in tissue and liquid biopsy

Whole Genome and Transcriptome Analysis of Anaplastic Meningioma. Patrick Tarpey Cancer Genome Project Wellcome Trust Sanger Institute

ACE ImmunoID Biomarker Discovery Solutions ACE ImmunoID Platform for Tumor Immunogenomics

Breast and ovarian cancer in Serbia: the importance of mutation detection in hereditary predisposition genes using NGS

Cancer Gene Panels. Dr. Andreas Scherer. Dr. Andreas Scherer President and CEO Golden Helix, Inc. Twitter: andreasscherer

Advance Your Genomic Research Using Targeted Resequencing with SeqCap EZ Library

Enterprise Interest Thermo Fisher Scientific / Employee

Liquid biopsy in lung cancer: The EGFR paradigm

Personalized Medicine: Lung Biopsy and Tumor

DNA-seq Bioinformatics Analysis: Copy Number Variation

Supplementary Tables. Supplementary Figures

MET skipping mutation, EGFR

Supplementary Online Content

Tumor mutational burden and its transition towards the clinic

Fluxion Biosciences and Swift Biosciences Somatic variant detection from liquid biopsy samples using targeted NGS

Next generation diagnostics Bringing high-throughput sequencing into clinical application

An ultrasensitive method for quantitating circulating tumor DNA with broad patient coverage

QIAGEN Complete Solutions for Liquid Biopsy Molecular Testing

Analysis with SureCall 2.1

The feasibility of circulating tumour DNA as an alternative to biopsy for mutational characterization in Stage III melanoma patients

Dr Yvonne Wallis Consultant Clinical Scientist West Midlands Regional Genetics Laboratory

ACE ImmunoID. ACE ImmunoID. Precision immunogenomics. Precision Genomics for Immuno-Oncology

NGS ONCOPANELS: FDA S PERSPECTIVE

AD (Leave blank) TITLE: Genomic Characterization of Brain Metastasis in Non-Small Cell Lung Cancer Patients

NEXT GENERATION SEQUENCING. R. Piazza (MD, PhD) Dept. of Medicine and Surgery, University of Milano-Bicocca

An innovative multi-dimensional NGS approach to understanding the tumor microenvironment and evolution

Simple, rapid, and reliable RNA sequencing

Joachim Aerts Erasmus MC Rotterdam, Netherlands. Drawing the map: molecular characterization of NSCLC

Comprehensive Genomic Profiling, in record time. Accurate. Clinically Proven. Fast.

Pathologists role Ancillary Studies in Cytology Challenges. Pre-analytical issues. LUNG CYTOLOGY Predictive markers and molecular tests

Aliccia Bollig-Fischer, PhD Department of Oncology, Wayne State University Associate Director Genomics Core Molecular Therapeutics Program Karmanos

Integration of Cancer Genome into GECCO- Genetics and Epidemiology of Colorectal Cancer Consortium

Accel-Amplicon Panels

New Drug development and Personalized Therapy in The Era of Molecular Medicine

Robert Beer

Molecular Genetics of Paediatric Tumours. Gino Somers MBBS, BMedSci, PhD, FRCPA Pathologist-in-Chief Hospital for Sick Children, Toronto, ON, CANADA

Multiplex target enrichment using DNA indexing for ultra-high throughput variant detection

Integration of Genomics Into Clinical Pathways. Precision Medicine and Decision Support

Next-generation sequencing based clinical testing for lung cancer in Japan

Delivering Value Through Personalized Medicine: An Industry Perspective

Please Silence Your Cell Phones. Thank You

Supplementary Figure 1. Schematic diagram of o2n-seq. Double-stranded DNA was sheared, end-repaired, and underwent A-tailing by standard protocols.

Golden Helix s End-to-End Solution for Clinical Labs

SureSelect Cancer All-In-One Custom and Catalog NGS Assays

Genomics in the Clinical Practice - Today and Tomorrow

Qué hemos aprendido hasta hoy? What have we learned so far?

A complete next-generation sequencing workfl ow for circulating cell-free DNA isolation and analysis

Performance Characteristics BRCA MASTR Plus Dx

December 13, The Future Reimbursement Environment for NGS for Oncology

Disclosure. Summary. Circulating DNA and NGS technology 3/27/2017. Disclosure of Relevant Financial Relationships. JS Reis-Filho, MD, PhD, FRCPath

Reporting TP53 gene analysis results in CLL

Tissue or Liquid Biopsy? ~For Diagnosis, Monitoring and Early detection of Resistance~

NCRI Biomarkers & Imaging CSG Cell-free DNA workshop

Matthew Smolkin, MD HCLD Medical Director Molecular Pathology Diagnostic Laboratory

GENETIC TESTING FOR TARGETED THERAPY FOR NON-SMALL CELL LUNG CANCER (NSCLC)

PRECISION INSIGHTS. GPS Cancer. Molecular Insights You Can Rely On. Tumor-normal sequencing of DNA + RNA expression.

Illumina Trusight Myeloid Panel validation A R FHAN R A FIQ

NGS IN ONCOLOGY: FDA S PERSPECTIVE

Molecular Targets in Lung Cancer

Circulating Tumor DNA in GIST and its Implications on Treatment

5 th July 2016 ACGS Dr Michelle Wood Laboratory Genetics, Cardiff

Investigating rare diseases with Agilent NGS solutions

Molecular Testing Updates. Karen Rasmussen, PhD, FACMG Clinical Molecular Genetics Spectrum Medical Group, Pathology Division Portland, Maine

:00-13:00 Industry Satellite Symposium 1 Room A. 13:00-13:30 Welcome reception Hall 1. 13:30-13:45 Opening and welcome Room B

The oncologist s point of view: the promise and challenges of increasing options for targeted therapies in NSCLC

Refining Prognosis of Early Stage Lung Cancer by Molecular Features (Part 2): Early Steps in Molecularly Defined Prognosis

Circulating Tumor DNA for Management of Non-Small-Cell Lung Cancer (Liquid Biopsy)

Abstract. Optimization strategy of Copy Number Variant calling using Multiplicom solutions APPLICATION NOTE. Introduction

Liquid biopsy: the experience of real life case studies

Supplementary Appendix

September 23, The Role of In Vitro Diagnostic Tests in Pediatric Master Protocol Development

Patient Leader Education Summit. Precision Medicine: Today and Tomorrow March 31, 2017

MP Circulating Tumor DNA Management of Non-Small-Cell Lung Cancer (Liquid Biopsy)

TARGETED THERAPY FOR LUNG CANCER. Patient and Caregiver Guide

David Tamborero, PhD

Current practice, needs and future directions in immuno-oncology research testing

Genomic Medicine: What every pathologist needs to know

Comprehensive genomic profiling for various solid tumors

IntelliGENSM. Integrated Oncology is making next generation sequencing faster and more accessible to the oncology community.

Molecular Testing in Lung Cancer

Precision Genetic Testing in Cancer Treatment and Prognosis

Medical Policy An independent licensee of the Blue Cross Blue Shield Association

ECMC cfdna consensus meeting

Cytogenetics 101: Clinical Research and Molecular Genetic Technologies

Characterisation of structural variation in breast. cancer genomes using paired-end sequencing on. the Illumina Genome Analyser

ncounter Assay Automated Process Immobilize and align reporter for image collecting and barcode counting ncounter Prep Station

Personalised medicine: Past, present and future

Lukas Bubendorf Pathologie. Liquid biopsies

Personalized Genetics

Beyond ALK and EGFR: Novel molecularly driven targeted therapies in NSCLC Federico Cappuzzo AUSL della Romagna, Ravenna, Italy

Evaluation of MIA FORA NGS HLA test and software. Lisa Creary, PhD Department of Pathology Stanford Blood Center Research & Development Group

2/10/2016. Evaluation of MIA FORA NGS HLA test and software. Disclosure. NGS-HLA typing requirements for the Stanford Blood Center

GPS Cancer. The Era of Complete Genomics and Proteomics is Here. Advanced molecular profiling to inform personalized treatment strategies

Supplementary Methods

Lyon, 1 3 February 2012 Auditorium

Clinical Grade Biomarkers in the Genomic Era Observations & Challenges

New technologies reaching the clinic

Small RNA Sequencing. Project Workflow. Service Description. Sequencing Service Specification BGISEQ-500 SERVICE OVERVIEW SAMPLE PREPARATION

Transcription:

NGS in Cancer Pathology After the Microscope: From Nucleic Acid to Interpretation Michael R. Rossi, PhD, FACMG Assistant Professor Division of Cancer Biology, Department of Radiation Oncology Department of Pathology and Laboratory Medicine Emory University School of Medicine

Disclosures Not a paid consultant to Agilent, nor a share holder 2

Outline 1. Introduction to Cancer Genomics 2. NGS Oncology Assay Basics a. Instrument Footprint b. Nucleic Acid: DNA, RNA, Both? c. Library Prep: Hybrid Capture vs Amplicon d. Sequencing: Depth of Coverage and Data Quality e. Bioinformatics: Compute, Storage, Workflow f. Data Interpretation: Knowledge is power g. Reporting 3. Questions 3

Cancer Genomics 4

5

TCGA PanCancer Data Cirello et al., Nature Genetics 45, 1113 1120 (2013) 6

Cirello et al, Emerging landscape of oncogenic signatures across human cancers Nature Genetics 45, 1127 1133 (2013), 7

Genomic Medicine 101 8

Lung Cancer Mutation Consortium v1 From: Using Multiplexed Assays of Oncogenic Drivers in Lung Cancers to Select Targeted Drugs JAMA. 2014;311(19):1998-2006. doi:10.1001/jama.2014.3741 Figure Legend: Survival Comparisons ALK indicates anaplastic lymphoma kinase gene; EGFR(s), epidermal growth factor receptor gene (sensitizing); EGFR(o), epidermal growth factor receptor gene (other); KRAS, Kirsten rat sarcoma; NA, not applicable.a, Median survival (95% CI): oncogenic driver + no targeted therapy, 2.38 (1.81-2.93); oncogenic driver + targeted therapy, 3.49 (3.02-4.33); no oncogenic driver, 2.08 (1.84-2.46). B, Survival by oncogenic driver detected for patients with the 5 most frequent oncogenic drivers and targeted treatment. Median survival (95% CI): EGFR(s), 3.78 (2.77-NA); EGFR(o), 2.70 (1.42-NA); ALK, NA (2.80-NA); KRAS, 4.85 (1.30-NA); doubletons (oncogenic drivers in 2 genes), 2.69 (1.94-NA). Vertical tick marks are censoring events. Copyright 2014 American Medical Association. All rights reserved.

Acquired Resistance to Lorlatinib and Resensitization to Crizotinib in NSCLC Shaw AT et al. N Engl J Med 2016;374:54-61.

Figure 1: Somatic mutation frequencies observed in exomes from 3,083 tumour normal pairs Lawrence et al., Mutational heterogeneity in cancer and the search for new cancer-associated genes. Nature 499, 214 218 (11 July 2013) 11

12

Oncology Testing Paradigm Initial Diagnosis Comprehensive Testing (Discovery) Hybrid Capture RNA-Seq (Differential Gene Expression, Coding Fusions/Mutations) Hybrid Capture DNA-Seq (Copy Number, Mutations, Fusions) Minimal Residual Disease Targeted Testing (Response to Treatment) Ultra Deep DNA Sequencing Neoantigen ctdna/exome (Digital PCR, Lower complexity Hybrid Capture or Amplicon NGS Panels) Disease Progression Comprehensive Testing (Discovery) RNA-Seq (Differential Gene Expression, Coding Fusions/Mutations) Hybrid Capture DNA-Seq (Copy Number, Mutations, Fusions) 13

Data Management 14

NGS Oncology Assay Basics Instrument Footprint Nucleic Acid: DNA, RNA, Both? Library Prep: Hybrid Capture vs Amplicon Sequencing: Depth of Coverage and Data Quality Bioinformatics: Compute, Storage, Workflow Data Interpretation: Knowledge is power Reporting 15

Laboratory Management System (LIMS) Nucleic Acid QC Spectrophotometer Pico Green Fluorometer DIN/RIN Measurement Quantitative PCR Library Prep Automation / Liquid Handling Sequencer Compute and Storage (Cloud vs Local) 16

NGS Oncology Assay Basics Instrument Footprint Nucleic Acid: DNA, RNA, Both? Library Prep: Hybrid Capture vs Amplicon Sequencing: Depth of Coverage and Data Quality Bioinformatics: Compute, Storage, Workflow Data Interpretation: Knowledge is power Reporting 17

18

NGS Oncology Assay Basics Instrument Footprint Nucleic Acid: DNA, RNA, Both? Library Prep: Hybrid Capture vs Amplicon Sequencing: Depth of Coverage and Data Quality Bioinformatics: Compute, Storage, Workflow Data Interpretation: Knowledge is power Reporting 19

DNA and RNA Libraries Hybrid Capture Whole Transcriptome Fusions Amplicon (PCR) 20

NGS Oncology Assay Basics Instrument Footprint Nucleic Acid: DNA, RNA, Both? Library Prep: Hybrid Capture vs Amplicon Sequencing: Depth of Coverage and Data Quality Bioinformatics: Compute, Storage, Workflow Data Interpretation: Knowledge is power Reporting 21

Uniform Coverage 0-213 0-221 0-208 0-208 22

Mutation Detection Total count: 212 A : 0 C : 66 (31%, 40+, 26- ) G : 0 T : 146 (69%, 95+, 51- ) N : 0 KRAS c.436g>a [p.a146t] _ENST00000256078 23

NGS Oncology Assay Basics Instrument Footprint Nucleic Acid: DNA, RNA, Both? Library Prep: Hybrid Capture vs Amplicon Sequencing: Depth of Coverage and Data Quality Bioinformatics: Compute, Storage, Workflow Data Interpretation: Knowledge is power Reporting 24

Bioinformatics Conundrum? Expensive Complicated 25

FASTQ Data QC Align (.BAM/.BAI) Call Variants (.VCF) Annotate (.MAF/.TSV) https://www.coursera.org/learn/galaxy-project 26

Galaxy Workflows http://goeckslab.org/ Jeremy Goecks GEORGE WASHINGTON UNIVERSITY 27

NGS Oncology Assay Basics Instrument Footprint Nucleic Acid: DNA, RNA, Both? Library Prep: Hybrid Capture vs Amplicon Sequencing: Depth of Coverage and Data Quality Bioinformatics: Compute, Storage, Workflow Data Interpretation: Knowledge is power Reporting 28

GIGO- Garbage In, Garbage Out The integrity of the output is dependent on the integrity of the input. George Fuechsel

C>T or G>A Lawrence et al., Nature 499, 214 218 (11 July 2013) 30

Is a normal control required to call somatic or germline mutations? No Yes 31

NGS Oncology Assay Basics Instrument Footprint Nucleic Acid: DNA, RNA, Both? Library Prep: Hybrid Capture vs Amplicon Sequencing: Depth of Coverage and Data Quality Bioinformatics: Compute, Storage, Workflow Data Interpretation: Knowledge is power Reporting 32

Lung Cancer Biomarkers Guidelines 33

34

Questions? 35 PR7000-0257