Next Generation Dx Summit

 Next Generation Sequencing as a Diagnostics Platform 

Monday, August 19 | 2:00 pm – 5:00 pm

 

The Landscape of Next Generation Sequencing and Challenges for Clinical Applications

Martin Siaw, Ph.D., Staff Scientist and Associate Director, Advanced Sequencing Core, Advanced Sequencing, Quest Diagnostics Nichols Institute

The rapid evolution of sequencing technologies presents many exciting opportunities as well as many challenges. The most significant challenges may well be for clinical diagnostics as the rapid evolution of platforms, protocols, kits, and reagents warrant careful consideration when developing and validating assays using Next Generation Sequencing technology. The technical landscape of advanced sequencing will be reviewed and some specific clinical applications presented in the context of the challenges presented by these power new technologies.

Attendees will:

  • Understand the technology landscape of next generation sequencing and new, emerging sequencing technologies.
  • Be introduced to challenges of NGS specific to CLIA lab environments.
  • Learn to identify key development and validation criteria for use in NGS assays.
  • Be given specific examples of clinical applications using advanced sequencing technologies. 

Application of Next-Generation Sequencing to Cancer Clinical Trials
Barbara A. Conley MD Associate Director, Cancer Diagnosis Program and Clinician investigator Division of Cancer Treatment and Diagnosis, NCI
P. Mickey Williams, Ph.D., Director, Molecular Characterization Laboratory, Frederick National Laboratory for Cancer Research

Multiplex molecular testing is increasingly being used in “umbrella” clinical trials, where patients are assigned to treatment based on “actionable” molecular characteristics in their tumors. The challenges in designing and conducting such clinical trials so that they inform further drug development and improvement in patient treatment are many.  The challenges in designating a given molecular difference as “actionable”, particularly in early phase clinical trials, as well as regulatory issues and assay validation methods will be discussed, with reference to two NCI clinical trials in development. Specific topics include how to define “actionable”, the importance of tumor enrichment, need for ultra-deep sequence coverage and clinical/analytical validation.

Attendees will:

• Describe the NGS pipeline employed in clinical cancer diagnostic labs.
• Understand cancer-specific challenges.
• Understand the clinical NGS validation approach.

Development of Laboratory Standards for Next-Generation Sequencing as a Clinical Tool
 Nazneen Aziz, Ph.D., Director of Molecular Medicine, Transformation Program Office, College of American Pathologists  

The rapid evolution of next generation sequencing (NGS) technologies presents significant opportunities and challenges for researchers and clinicians for improving health outcomes; particularly with respect to an increased emphasis on personalized and preventive medicine. Adoption of NGS in the clinical laboratory setting requires the adoption of many processes and procedures, such as, the analytic and clinical validation of the test, CLIA/CAP certification, standards for reference materials for proficiency testing, and questions regarding reimbursement and informed consent. This talk will cover what is practically needed for clinical adoption of NGS such as regulatory and professional standards, development, availability, and access to reference materials, and the laboratory professional's role for ensuring high quality test results that are useful for informing clinical decision making. Dr. Aziz will focus on the laboratory accreditation standards being developed at CAP for NGS in collaboration with ACMG and AMP.

 

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