2013 Archived Content
Monday, November 4, 6:00-9:00 pm
SC2: Fit-for-Purpose Biomarker Assay Development and Validation
John L. Allinson, FIBMS, Vice President, Biomarker Laboratory Services, ICON Development Solutions
This tutorial will provide recommendations on the “fit-for-purpose” best practices in the development and validation of biomarker assays for exploratory or advanced biomarker applications. Strategies for different applications at various phases of biomarker development will be described. Key elements in the method of development and validation will be illustrated with examples, including reference to standard material, sample stability and collection integrity, validation and QC samples, validity of reference standards, calibration curve fitting methods, method optimization and feasibility studies. Special challenges in protein biomarker assays will be discussed, including strategies for moving from biomarker panels in the exploratory phase to the few markers chosen to support clinical trials, cross-validation of biomarker assays, etc.
- Introduction: nomenclature, types of biomarker methods/assays, method development and validation roadmap, fundamental validity, similarity and differences from PK assays and diagnostic applications
- Pre-analytical and bioanalytical elements: target range, standards, validation and QC samples, stability, matrix effect, specificity and relative selectivity
- Calibration curve model selection, evaluation and weighting
- Method feasibility and optimization with precision profiles
- Evaluation of some pre-study validation characteristics such as precision, bias, sensitivity and quantification limits
- Use of sample controls for in-study performance monitoring and conformance testing among laboratories
- Special considerations for multiplex assays, cross-validation of assays, etc.
- Method comparisons
Tuesday, November 5, 6:00-9:00 pm
SC3: Next-Generation Sequencing as a Clinical Test
Nazneen Aziz, Ph.D., Director, Molecular Medicine, Transformation Program Office, College of American Pathologists
Seth Crosby, M.D., Director, Partnerships & Alliances, Washington University School of Medicine
Next-Generation Sequencing (NGS) is used widely in clinical research for the discovery of disease-associated genes and the clinical community is beginning to embrace this technology for diagnostic testing. The rapid evolution of 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 certification/CAP accreditation, standards for reference materials, availability for proficiency testing, and questions regarding reimbursement and informed consent. The success of NGS as a viable diagnostic modality depends on many branches of the healthcare community working together. This session will be informative and practical for the researcher and laboratorians who are considering launching NGS as a clinical test.
SC4: Preclinical Tumor Models
*Separate registration required