Visit SeraCare at the AMP 2019 Annual Meeting & Expo
Join us in Baltimore for the 25th anniversary of one of the most important molecular diagnostics events of the year.
Download our Featured AMP Posters
Join us for two fantastic corporate workshops to learn clinical laboratory best practices for tumor mutational burden (TMB) measurement using targeted NGS panels, and a panel discussion about technical and regulatory issues involved in designing fit-for-purpose NGS control materials. Meet our R&D scientists and see our latest research in the poster sessions. See details on both below.
Visit us at booth 2612 to learn about:
- Industry-first tumor mutational burden reference standards for improving and harmonizing TMB measurement by targeted NGS panels
- Clinical genomics reference materials for validation and routine QC of NGS-based biomarker assays for fusion RNAs and other clinically actionable markers
- How to ensure confidence in your NGS-based liquid biopsy, solid tumor, hematological malignancy, and germline testing results
Complete this form for your free AMP poster downloads:
CORPORATE WORKSHOP
Technical and Regulatory Considerations for Designing Next-Generation Sequencing
Controls and Standards for Optimal Quality and Performance: A Panel Discussion
Wednesday, November 6, 2019 at 8:00am, Room 309, Baltimore Convention Center
Next-generation sequencing (NGS) has become the main technology for advanced molecular cancer diagnostics. Today, testing is expanding beyond laboratory-developed tests to companion diagnostics and manufactured gene-targeted IVDs. Developing kits and complete systems for highly multiplexed NGS assays requires special consideration for the design and manufacture of controls that meet regulatory requirements and provide rigorous quality assessments for each step in the NGS workflow. Hear invited panelists from industry, clinical labs, and a regulatory agency share their perspectives and experiences on the critical technical and regulatory issues around designing fit-for-purpose control materials for solid tumor and liquid biopsy IVD assays.
Featured Speakers
Bob Daber, PhD, DABMG
President & CTO Genosity
Russell Garlick, PhD
CSO SeraCare Life Sciences
Federico Goodsaid, PhD
Principal Consultant Regulatory Pathfinders
Karen Gutekunst, PhD
VP, Regulatory Affairs Illumina
Jinjie Hu, PhD
President and Principal Consultant Axteria BioMed Consulting, Inc
CORPORATE WORKSHOP
New Tools and Strategies for High Quality TMB Analysis by NGS
Wednesday, November 6, 2019 at 4:00pm, Room 309, Baltimore Convention Center
Tumor mutational burden (TMB) is an increasingly important clinical biomarker for emerging immuno-oncology (IO) therapeutics. Join us for a clinical laboratory’s perspective on validating targeted NGS panels to support IO clinical trial projects using the first of its kind, purpose-built TMB reference materials. We will discuss the challenges of accurately measuring TMB in blood and tissue, and the development and application of reference materials to ensure the quality, standardization, and harmonization of TMB measurement by NGS.
Featured Speakers
Russell Garlick, PhD
CSO SeraCare Life Sciences
Ravindra Kolhe, MD, PhD
Vice Chairman of Pathology & Chief, Section of Molecular & Genetic Pathology Medical College of Georgia at Augusta University
Yves Konigshofer, PhD
Director, Technology Development SeraCare Life Sciences
Victor Weigman, PhD
Director, Translational Genomics Q2 Solutions
Scientific Poster Presentations
Friday, November 8 ~ 2:30pm - 3:30pm
ST084 - Characterization of Tumor-Normal Cell Line Pairs for TMB Standardization
ST124 - Highly efficient capture of small (sub-nucleosomal) ctDNA fragments.
TT040 - Establishing the Sensitivity, Specificity, Interlaboratory Reproducibility, and Analytical Limit of Detection of the UltraSEEK Liquid Biopsy Application Using Well-Defined Seraseq Reference Materials
Saturday, November 9 ~ 9:45am – 10:45am
ST099 - A Multi-Laboratory Investigation of 18 Oncogenic RNA Fusions in FFPE and Purified RNA-based Reference Materials
TT001 - Development of SNP-Matched NIPT Reference Materials for Validation, Proficiency Testing and Quality Control
TT023 - Circulating Tumor DNA (ctDNA) Reference Materials for Commercial RT-PCR Assays
TT027 - Amplified ccfDNA for Assay Development, Validation, and Proficiency Testing