Clinical Next-Gen Tumor Sequencing:

Transcription

1 Clinical Next-Gen Tumor Sequencing: Your Key to the Value-Driven Oncology Market Everything you need to know about implementing and optimizing next-gen tumor sequencing at your lab.

2 The demand for oncology-specific NGS testing is growing fast. Prepare your lab for this important new opportunity. Clinical Next-Gen Tumor Sequencing: Your Key to the Value-Driven Oncology Market Cancer care is one of the top three most expensive medical cost categories in the U.S. Yet a significant portion of that spending fails to improve outcomes. Because of the cost and quality of care challenges, payers have identified oncology as a key target for value improvement. And yet, various pilot programs have not yet thoroughly examined the role of next-generation sequencing (NGS) in value improvement even though it has the potential to lower the cost and improve the quality of cancer care. For example: NGS streamlines the diagnostic process by providing a comprehensive and precise diagnosis up-front in one test. NGS helps reduce wasteful spending on ineffective treatment and improve clinical outcomes by guiding patients to more effective and potentially lasting targeted single therapies or combinations of therapies. NGS helps better serve patients with unmet needs, including patients with rare cancer types or aggressive cancer forms for which there is no standard care, and those who have exhausted all standard treatment options. NGS helps identify end-of-life (EOL) patients in need of palliative care. That s where Clinical Next-Gen Tumor Sequencing comes in. This new report from G2 Intelligence is the ONLY comprehensive resource that covers the how, why and best practices of NGS for oncology PLUS projections, analysis, and value-based benefits for your organization. Its main purpose is to evaluate clinical adoption of NGS in oncology to date, including both clinical trials and commercial clinical testing for cancer patient care, and project future adoption. Specifically, the research focuses on clinical NGS testing for tumors, including both solid tumors (e.g., cancers of lung, breast, prostate, or colon) and liquid tumors (e.g., lymphomas, leukemias). Example Current and Projected Adoption of NGS Tumor Testing in Clinical Laboratories Percentage of Oncology Laboratories Offering NGS Tests 29% 35% 41% 51% 60% As the paradigm shifts away from 'one drug fits all' to 'mechanism-matched' trials, NGS is becoming a necessity. Partnerships with pharmaceutical companies or CROs have the promise to drive revenues for early adopters. Excerpt, Clinical Next-Gen Tumor Sequencing A comprehensive 150+ page report, supported by over 50 data-rich tables and charts. 7% Source: G2 Intelligence Order your copy today! Click Here!

3 Clinical Next-Gen Tumor Sequencing provides a wealth of exclusive, hard-to-find intelligence including: Overview and Trends Next-Generation Sequencing: Oncology, with discussions on: Cost Curve Decline: Faster than Moore s Law NGS Tumor Profiling: Tumor Markers and Targeted Therapies NGS Vendors, Regulatory and Validation Landscape, and Reimbursement Clinical Adoption: An Inflection Point Nears, featuring: Primary Factors that Hindered Clinical NGS Adoption From Barriers to Drivers: NGS Adoption Dynamics Changing Paradigm Shift in Oncology Clinical Trials Early Adopters: Approaches, Opportunities, and Challenges, with: Implementing NGS Oncology Testing Case Studies Market Opportunities for Early Adopters Challenges Facing Early Adopters Competing in a Value-Driven Market, with insights on: Role of NGS in a Value-Driven Market NGS Market Entry: Four Key Value Strategies for Clinical Laboratories The NGS Value Advantage APPENDIX A: NGS Platforms from Leading Vendors APPENDIX B: FDA-Approved Cancer Drugs and Associated Biomarkers. Order now and receive your copy for $1,195 by Clicking Here! To find out more, or to place your order by phone, please call or , us at CustomerService@G2Intelligence.com, or fax the order form on the back to G2 Intelligence research is priced for one authorized user only. For more information and custom licensing solutions for multiple users that will keep your organization in compliance with U.S. Copyright Laws, please contact Randy Cochran, randy@plainlanguagemedia.com or call About the Analysts Jenny Xu, Ph.D., Director of Research Xu leads G2's primary market research, secondary research, and syndicated industry analysis. Prior to joining G2, Xu worked at the global consultancy ZS Associates and the full service market research firm, Harris Interactive. Xu earned her Ph.D. with honors from the Annenberg School for Communication at the University of Southern California. L. Eleanor J. Herriman, M.D., M.B.A., Managing Director, Advisory Services Herriman is a pathologist executive with 15+ years experience in the medical technology industry. She leads G2 s advisory services, which provides strategic consulting and custom market research and assessments for a range of clients, and is the author of three G2 reports. Her market experience spans the clinical laboratory, in vitro diagnostics, and strategy consulting for Bain & Company. Herriman earned her M.D. at Baylor College of Medicine, and received an M.B.A. from Harvard Business School. About G2 Intelligence Advancing the Business of Diagnostic Medicine G2 Intelligence provides timely, accurate and trusted analysis of industry and market trends, legal and regulatory developments, and technology and innovation that directly affect the operations, financial performance, and competitive position of diagnostic testing laboratories and related medical services providers. Our mission is to deliver relevant, meaningful and actionable findings on diagnostic industry markets, related regulatory changes, and lab operations. The organization strives to exceed client expectations and develop mutually beneficial relationships with industry leaders and influencers. To order by phone, please call G2 Customer Care at , or CustomerService@G2Intelligence.com

4 Clinical Next-Gen Tumor Sequencing: Your Key to the Value-Driven Oncology Market Table Of Contents Table of Contents CHAPTER 1: Overview and Trends...7 Report Objective...7 Target Audience...7 Study Scope...7 Methodology...7 Report Overview...8 CHAPTER 2: Next-Generation Sequencing: Oncology...21 What Is Next-Generation Sequencing? Cost Curve Decline: Faster than Moore s Law NGS Tumor Profiling: Tumor Markers and Targeted Therapies NGS Vendors NGS Regulatory and Validation Landscape NGS Reimbursement CHAPTER 3: Clinical Adoption: An Inflection Point Nears...53 Summary Primary Factors That Hindered Clinical NGS Adoption From Barriers to Drivers: NGS Adoption Dynamics Changing in the Coming Three to Five Years Paradigm Shift in Oncology Clinical Trials: New Laboratory Revenue Opportunities with Pharmas NGS Clinical Adoption to Date...74 Prediction of Future Adoption...76 CHAPTER 4: Early Adopters: Approaches, Opportunities, and Challenges...85 Implementing NGS Oncology Testing Case Studies Market Opportunities for Early Adopters Challenges Facing Early Adopters CHAPTER 5: Competing in a Value-Driven Market Role of NGS in a Value-Driven Market NGS Market Entry: Four Key Value Strategies for Clinical Laboratories The NGS Value Advantage APPENDIX A: NGS Platforms from Leading Vendors APPENDIX B: FDA-Approved Cancer Drugs and Associated Biomarkers About the Analysts About G2 Intelligence Notice: No part of this publication may be reproduced, stored in a retrieval system or transmitted by any means, electronic or mechanical, without the prior written permission of Plain Language Media, LLLP, New London, CT, USA Plain Language Media, LLLP iii

5 Clinical Next-Gen Tumor Sequencing: Your Key to the Value-Driven Oncology Market Table of Figures The Clinical Value of NGS Tumor Profiling...9 Laboratories Currently Offering Clinical NGS Tumor Tests for Patient Care...12 Current and Projected Adoption of NGS Tumor Testing in Clinical Laboratories...13 Landscape of Approaches to NGS...14 NGS across the Oncology Care Continuum...16 Integrated Model of Cancer Genomics...20 Steps Involved in DNA Sequencing...21 Comparison of Second-Generation Sequencing (NGS) Methods...23 Cost of Genome Sequencing Outpaces Moore s Law...26 The Clinical Value of NGS Tumor Profiling...28 Current Molecular Markers with Established or Emerging Evidence of Clinical Utility...29 Predictive Biomarkers and Associated Cancer Therapies...30 Efforts to Include NGS in Oncology Clinical Trials...32 Frequency of Mutations and Availability of Targeted Therapies in NSCLC...35 Leading NGS Sequencing Platform Vendors and System Costs...36 NGS Platforms by Capability...37 Comparison of Leading NGS Platforms...38 NGS Platforms Used in Clinical Laboratories...38 Major Steps in Clinical NGS Testing...40 NGS Bioinformatics Vendors in the U.S...41 NGS Interpretation Vendors in the U.S...42 Opportunities for Standardization in Clinical NGS Testing...43 Process for Implementing Clinical NGS Testing...45 CAP Accreditation Checklist Themes...46 CAP NGS Proficiency Testing Framework...47 Molecular Profiling Technologies...58 Two Design Approaches to Clinical Trials...70 Vendors Offering NGS Tumor Profiling for Pharmaceutical Companies...74 Clinical Laboratories Currently Offering NGS Tumor Tests for Patient Care...75 Current and Projected Adoption of NGS Tumor Testing in Clinical Laboratories...77 Foundation Medicine Annual Test Volume P...79 Foundation Medicine Annual Revenue P...79 Foundation Medicine Quarterly Test Volume in Foundation Medicine Quarterly Revenue in Foundation Medicine Revenue Growth by Source: Commercial Clinical Testing vs. Pharmaceutical Partnership...81 Foundation Medicine Revenue Share by Source: Commercial Clinical Testing vs. Pharma Partnership...81 Approaches to Establishing NGS Testing in Clinical Laboratories...85 Landscape of Approaches to NGS...86 Driver Mutations in Lung Adenocarcinoma...91 The Long Tail of Genomic Alterations: Non-Small Cell Lung Cancer (NSCLC)...93 Examples of Differing Panel Sizes...95 iv 2014 Plain Language Media, LLLP Notice: No part of this publication may be reproduced, stored in a retrieval system or transmitted by any means, electronic or mechanical, without the prior written permission of Plain Language Media, LLLP, New London, CT, USA.

6 Clinical Next-Gen Tumor Sequencing: Your Key to the Value-Driven Oncology Market PathGroup and SCRI Partner to Pre-Screen Cancer Patients for Trials Foundation Medicine Customer Base Foundation Medicine Reimbursement History June 2012 December Foundation Medicine Sales Team Expansion Average Reimbursement per Test for FoundationOne (Commercial Third-Party Payers Only) Pathology across the Continuum of Cancer Care Foundation Medicine Commercial Clinical Testing Revenue and Share Foundation Medicine Quarterly Test Volume Q Q Spending on Responders vs. Non-Responders to Top 10 Cancer Drugs UnitedHealthcare s Bundled Payment Model Comparing Value-Based Care and Payment Models Illumina NGS Platforms Thermo Fisher Scientific Ion Torrent Thermo Fisher Scientific SOLiD FDA-Approved Cancer Drugs and Associated Biomarkers Notice: No part of this publication may be reproduced, stored in a retrieval system or transmitted by any means, electronic or mechanical, without the prior written permission of Plain Language Media, LLLP, New London, CT, USA Plain Language Media, LLLP v