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The technology of companion diagnostics is going through the most significant change since the establishment of the concept of personalized medicine. The reason and the main driver of this change is the next generation sequencing and the option to check for several predictive biomarkers simultaneously. Another issue that complicates the steady progress of companion diagnostics is the current state of the reimbursement uncertainty in the area of molecular diagnostics. Our Fifth Annual Companion Diagnostics: Technology & Reimbursement conference will be featuring technological advances of companion assays both as IVD products and as laboratory developed tests. It will also address the pivotal issue of reimbursement with the emphasis on partnership between payers and assay developers.


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10:30 am Registration

PLENARY SESSION: Think Tank on Next-Generation Sequencing Diagnostics

11:00 Chairperson’s Opening Remarks

Harry Glorikian, Healthcare Consultant

11:10 Discussion: Regulatory Review of Clinical Sequencing Assays

Harry GlorikianModerator: Harry Glorikian, Healthcare Consultant


Jennifer DickeyGuest Speaker: Jennifer Dickey, RAC, Ph.D., Office of In Vitro Diagnostics, DIHD, US Food and Drug Administration


In November of 2013, the FDA issued the first clearances of Next Gen Sequencing- (NGS) based assays. There have additionally been a number of clinical trials approved recently that utilize NGS-based assays for patient enrollment or stratification. In light of the expanding roles that new sequencing technologies are playing in clinical decision making, this talk will focus on critical elements that FDA considers when evaluating NGS validation using the recent clearances/approvals as examples. There will also be a discussion of any new communications that FDA has issued in regard to the regulatory review of NGS- based assays. Following the discussion there will be a Q&A with the audience.

11:55 Next-Generation Sequencing in Clinical Practice: Case Reports of Clinical Utility and Reimbursement  

Elaine LyonModerator: Elaine Lyon, Ph.D., Medical Director, Molecular Genetics, ARUP


Case Presenters:

Andrea Ferreira-Gonzalez Andrea Ferreira-Gonzalez, Ph.D., Professor, Pathology; Director, Molecular Diagnostics Lab, Virginia Commonwealth University


Madhuri HegdeMadhuri Hegde, Ph.D., FACMG, Professor, Human Genetics; Executive Director, Emory Genetics Laboratory, Emory University School of Medicine


The landscape of next-generation sequencing diagnostics is changing rapidly. Clinical laboratories are offering highly complex tests using new technologies, but face challenges in reimbursement. To be reimbursed for these tests, laboratories will need to address clinical utility as well as clinical validity. Clinical cases that demonstrate the utility of genomic oncological and inherited disease testing will be presented. Experiences with reimbursement of these tests will be discussed.

12:40 pm Enjoy Lunch on Your Own


1:50 Chairperson’s Opening Remarks

Kenneth Emancipator, M.D., Merck Research Laboratories

2:00 Development and Clinical Impact of a Comprehensive NGS-Based Cancer Genomic Profiling

Roman YelenskyRoman Yelensky, Ph.D., Senior Director, Biomarker and Companion Diagnostic Development, Foundation Medicine

In recent years the field of oncology has experienced a paradigm shift toward thinking about cancer as a disease of the genome. Our understanding of cancer biology has been furthered through the use of next-generation sequencing (NGS) to more comprehensively characterize the genomic alterations in an individual patient’s cancer. Foundation Medicine has overcome key scientific and clinical challenges to develop a comprehensive profiling approach that, when used in a clinical trial setting, can help to decrease costs and overall time to market for targeted therapies, and when used in the clinic, can help to more appropriately identify candidates for therapy. Utilizing this approach enables more rapid trial accrual to ongoing and planned trials of agents targeting pathways under study and helps us to better understand the characteristics of responders and non-responders to therapy, accelerating the field towards precision medicine.

2:30 Personalized Genomic Analyses of Human Cancer

Victor E. VelculescuVictor E. Velculescu, M.D., Ph.D., Professor, Oncology; Co-Director, Cancer Biology, Johns Hopkins Kimmel Cancer Center

Analyses of cancer genomes have revealed mechanisms underlying tumorigenesis and new avenues for therapeutic intervention. We now face challenges in translating these analyses to the clinic as well as opportunities with development of new technologies to analyze molecular alterations in the circulation of cancer patients as cell-free tumor DNA. These approaches have important implications for therapeutic stratification, identification of mechanisms of resistance to targeted therapies, and non-invasive detection and monitoring of human cancer.

3:00 What Does the History of in vitro Diagnostics Tell Us About the Future of Personalized Medicine?

Kenneth EmancipatorKenneth Emancipator, M.D., Director, Companion Diagnostics, Merck Research Laboratories

The promise of personalized medicine is finally becoming a reality, as more drugs are regularly approved with companion diagnostics. However, as personalized medicine continues to progress, the current one-drug, one-test paradigm will become increasingly impractical. While next-generation sequencing (NGS) is certainly part of the solution, it is not a panacea. A look at how generally diagnostic testing evolved provides clues to the future of companion diagnostics and personalized medicine.


 Dako3:30 From Anatomical to Molecular: Technological Approaches for CDx Research and Development 

Sheila Purim, Ph.D., Director, Strategic Marketing, Diagnostics and Genome, Agilent Technologies Company

During this talk we will cover some past, current and emerging technologies being explored for research and development of Companion Diagnostic tools. We will highlight the advantages and pitfalls of such technologies and discuss the advantages of combining anatomical and molecular profiles for the analysis of tumor samples. Some research technologies that will be covered include: IHC, Next Generation Sequencing, Microarrays and FISH.

4:00 Refreshment Break in the Exhibit Hall with Poster Viewing

4:45 Use of POC in Oncology Outpatient Practices

Richard A. White, Ph.D., Director, Global Strategy, Breast and Colon Products, Genomic Health, Inc.

With the increased cost of treatment of patients in inpatient settings, economic pressure mounts to reduce overall cost of hospitalization for both acute and chronic treatment. Advances in treatment and diagnostic options have uncovered an opportunity for near-patient testing platforms to serve diagnostic and monitoring purposes.

5:15 NGS: The Case for Quality

Melina CimlerMelina Cimler, Ph.D., Vice President, Head, Global Quality, Illumina, Inc.

Through the Case for Quality, the FDA is working with stakeholders to foster medical device quality. Focus is shifting to critical-to-quality (CTQ) practices that, when present in day-to-day device design and production, correlate to higher-quality outcomes. With the rapid evolution of NGS technologies, the implementation of CTQ’s is challenging. What are the elements to successful quality practices.

5:45 Genome in a Bottle: A Benchmark to Understand Genome Sequencing Accuracy for Companion Diagnostics

Justin ZookJustin Zook, Ph.D., Biomedical Engineer, National Institute of Standards and Technology

Marc SalitMarc Salit, Ph.D., Genome-Scale Measurements Group Leader, National Institute of Standards and Technology

To help clinical and research labs understand the trustworthiness of variant calls from Next-Generation Sequencing, the Genome in a Bottle Consortium (www.genomeinabottle.org) is developing well-characterized whole human genomes. We will describe how labs are using our high-confidence SNP, indel, and homozygous reference genotypes for our pilot NIST human genome Reference Material, and our plans for future Reference Materials.

6:15 Close of Day

6:00 Dinner Short Course Registration


Recommended Dinner Short Course* 

6:30-8:30 pm Regulatory and Reimbursement Issues with NGS and Multiplex Assays

*Separate registration required

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