The isolation, sequencing and evaluation of cell-free DNA (cfDNA) for a variety of applications will be reviewed and the clinical utility of these new methods will be considered. The source of cell free DNA, methods to analyze it and use in clinical protocols will be measured against competing approaches such as circulating tumor cells. Cell free circulating DNA is being used to monitor disease recurrence, as a non invasive technique for prenatal testing and as a surrogate biomarker for cancer. Characterizing cancer based on genomic profiling of cfDNA will allow greater understanding of the biology and our ability to diagnose and treat it more effectively.
Regulatory Review of Clinical Sequencing Assays
In November of 2013 FDA issued the first clearances of NextGen Sequencing based assays. There have additionally been a number of clinical trials approved recently that utilize NextGen Sequencing 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 NextGen sequencing 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 NextGen sequencing-based assays.
Harry Glorikian, Managing Partner, Strategy, Precision for Medicine
Jennifer Dickey, RAC, Ph.D., Office of In Vitro Diagnostics, DIHD, US Food and Drug Administration
Next Generation Sequencing in Clinical Practice: Case Reports of Clinical Utility and Reimbursement
Elaine Lyon, Ph.D., Medical Director, Molecular Genetics, ARUP
Andrea Ferreira-Gonzalez, Ph.D., Professor, Virginia Commonwealth University
Madhuri Hegde, Ph.D., FACMG, Associate Professor, Human Genetics; Executive Director, Emory Genetics Laboratory, Emory University School of Medicine
Life at the Single-Molecule Level: Single-Cell Genomics
Sunney Xie, Ph.D., Mallinckrodt Professor of Chemistry, Department of Chemistry and Chemical Biology, Harvard University
Genome-Wide Mapping of DNA Rearrangements in Single Cells Using DNA Template Strand Sequencing
Peter M. Lansdorp, M.D., Ph.D., FRSC, Scientific Director, European Research Institute for the Biology of Ageing, University Medical Center, University of Groningen; Senior Scientist, Terry Fox Laboratory , BC Cancer Research Centre; Professor, Division of Hematology, Medicine, University of British Columbia
Introduction and Overview
Luis A. Diaz, M.D., Associate Professor, Oncology, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Conference Chairperson
Detection of Circulating Tumor DNA in Early and Late-Stage Human Malignancies
Chetan Bettegowda, M.D., Ph.D., Assistant Professor of Neurological Surgery, Johns Hopkins University School of Medicine
DNA Methylation Regulation
David Hoon, MSc, Ph.D., Director, Molecular Oncology, John Wayne Cancer Institute
Detection and Genotyping of Structural Alterations in the Circulation of Cancer Patients
Mark Sausen, Ph.D., Director, R&D, Personal Genome Diagnostics
Rapid Isolation and Detection of Cancer Related Circulating Cell Free DNA and RNA from Patient Blood and Plasma Samples
Michael J. Heller, Ph.D., Professor, Nanoengineering & Bioengineering, University of California San Diego
Non-Invasive Analysis of Mechanisms of Acquired Drug Resistance by Sequencing ctDNA
Muhammed Murtaza, Ph.D., Research Assistant Professor, TGen
Multi-Marker Analysis of Circulating Cell-Free DNA toward Personalized Medicine for Colorectal Cancer
Alain R. Thierry, Ph.D., Senior Investigator, Research Institute in Oncology of Montpellier, INSERM
Targeted Detection and Monitoring of Cell Free Tumor Tumor DNA in Urine
Jason C Poole, Ph.D., Director, Research & Development, Trovagene Inc.
An optimized isolation technique for cell-free DNA makes it possible to detect systemically derived of DNA in urine. Using a small footprint capture and enrichment technique, we demonstrate the analytical detection and quantification of these tumor fragments down to a sensitivity of less than 0.01%, creating a truly non-invasive cancer mutation detection platform.
Additional Sponsored Presentations by Transgenomic