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Emerging Molecular Markers of Cancer 

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7:30 am Problem Solving Breakout Discussions with Continental Breakfast

TABLE: Clinical Application of NGS

Moderator: Marilyn M. Li, M.D., Professor, Department of Molecular and Human Genetics, Baylor College of Medicine

• Pros and cons of whole genome/whole exome sequencing vs. targeted cancer gene panel sequecing
• Would you confirm mutations/variants identified? If yes, what would you confirm?
• Would you and how would you distinguish somatic mutations from germline mutations?
• Reporting: what should be reported?

TABLE: Cancer Stem Cell Biomarkers

Moderator: James Sherley, M.D., Ph.D., Senior Scientist, Programs in Regenerative Biology and Cancer Biology; Director, Adult Stem Cell Technology Center, Boston Biomedical Research Institute

• Addressing the biology versus the technology origin of "cancer stem cells"; tumor cell fractionation and tumor formation/progression
• The "expected" distribution of cancer stem cell fractions in human tumors based on the cell kinetics architecture of normal human tissues
• Relationships between normal tissue stem cell biomarkers and cancer stem cell biomarkers
• Evaluating cancer stem cell biomarkers and the natural history and treatment of human cancers

TABLE: Next-Gen Genomics and Solid Tumor Biomarkers

Moderator: George Netto, M.D., Associate Professor of Pathology, Urology and Oncology, Johns Hopkins University School of Medicine

• Where do you see clinical applications in 5 years?
• Patents and royalties of molecular testing in the era of genomics
• How personal can personalized therapy for solid tumors get?

TABLE: "Lost in Translation" - How to Turn Candidate Biomarkers into Validated Diagnostic Tests

Moderator: Yuling Luo, Ph.D., Founder, President & CEO, Advanced Cell Diagnostics, Inc.

• What are the current and new ways to validate biomarkers?
• What are the main issues in analytical and clinical validation of biomarker assays?
• What are the issues with various sample sources (e.g. blood, tissue) for biomarker analysis?
• What is the impact of cellular and tissue context on biomarker analysis and clinical utility?
• What is the impact of quantitation on biomarker analysis and clinical utility?
• How simple and robust should a clinical diagnostic test be?

Integration of NGS with other profiling platforms

Moderator: Elizabeth Mambo, Ph.D., Senior Scientist, Technology Development, Asuragen, Inc.

• What factors are most important to consider in the selection of a platform strategy for biomarker discovery?
• What approach is most efficient to reduce the number of candidate markers from genome-wide discovery efforts?
• What is the best way to address platform-specific biomarkers, i.e. differentially expressed genes (DEGs) that do not overlap among the platforms?
• How do NGS platforms compare for mutation detection? What is the best way to reconcile low level mutation detection between NGS platforms?
• What tools and approaches are available to integrate data from microarray, PCR, and NGS to improve the identification of biomarkers and disease-relevant pathways?


Cancer Stem Cell Markers: Proving Their Existence and Understanding Tumor Cell Heterogeneity 

8:55 Chairperson’s Opening Remarks

9:00 Cancer Stem Cells: To Believe or Not to Believe

Sunil-BadveSunil Badve, Ph.D., Associate Professor, Clarian Pathology Laboratory, Indiana University School of Medicine




9:30 Sponsored Presentations (Opportunities Available) 

10:00 Coffee Break in Exhibit Hall with Poster Viewing

10:30 Emerging Cancer Stem Cell Biomarkers Based on the “9th Hallmark of Cancer”

James-SherleyJames Sherley, M.D., Ph.D., Senior Scientist, Programs in Regenerative Biology and Cancer Biology; Director, Adult Stem Cell Technology Center, Boston Biomedical Research Institute

Carcinogenesis has been attributed to eight cellular alterations highlighted as the “Hallmarks of Cancer.” This representation overlooks a “9th Hallmark of Cancer,” the absolute requirement for originating tissue stem cells to shift from asymmetric self-renewal kinetics to increased symmetric self-renewal kinetics to achieve the cell production rates necessary to form clinically significant tumors. Biomarkers for asymmetric self-renewal are now emerging. Beyond identifying tissue stem cells, these novel biomarkers also have potential to be highly effective for detecting cancer stem cells.

11:00 Tracking Stem Cell Overpopulation during Colon Cancer Development

Bruce-BowmanBruce Boman, M.D., Thomas Jefferson University Hospital

Recent developments in the identification and isolation of colon cancer stem cells (SC) using SC markers will be discussed. The hypothesis is that the mechanism that links abnormalities at the gene level and abnormalities at the tissue level is stem cell overpopulation. The concept that symmetric cancer stem cell division is a key mechanism that drives tumor growth, and that development of a new generation of therapeutics that target colon cancer SC holds promise for patients with advanced colorectal cancers will also be addressed.

11:30 Transition to Plenary Session


Regulation of LDTs and RUOs

Alberto Gutierrez, Ph.D., Deputy Director, Office of in vitro Diagnostic Device Evaluation and Safety, Food & Drug Administration

Moderated by: Franklin R. Cockerill, III, M.D., Ann and Leo Markin Professor of Microbiology & Medicine; Chair, Department of Laboratory Medicine and Pathology, Mayo Clinic College of Medicine; President and CEO, Mayo Medical Laboratories and Mayo Collaborative Services, Inc.

12:45 pm Enjoy Lunch on Your Own


1:45 Views of the Laboratory Industry on Regulatory Issues

Alan Mertz, President, American Clinical Laboratory Association (ACLA)

2:10 Views of Diagnostics Manufacturers on Regulatory Issues

Andrew C. Fish, Executive Director, AdvaMedDx

2:30 Close of Emerging Molecular Markers of Cancer Conference

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