Videos

 

Case Study 3: Development and Validation of Clinical ctDNA Cancer Assays

Tony Godfrey of the Boston University School of Medicine will discuss how his lab is developing and validating clinical circulating tumor DNA assays.  

 

QC Systems to comply with CAP,CLIA and Regulatory state guidlnes

Case Study 2: QC Systems to Comply with CAP, CLIA, & State Regulatory Guidelines

Robert Daber, formerly of BioReference Laboratory, will discuss how labs can establish laboratory QC systems to comply with CAP, CLIA, and state regulatory guidelines. 


Case Study 1 Cancer Hotspot Assays

Case Study 1: Development and Validation of a Cancer Hotspot Assay

Gregory J. Tsongalis of Dartmouth Hitchcock Medical Center will discuss how his lab developed and validated a cancer hotspot assay. Webinar attendees will be able to ask questions during a live Q&A session.



Roundtable Discussion: Best Practices for Validation, Monitoring, and Controls

Expert panelists who will provide an overview of the current regulatory landscape for laboratory-developed tests, particularly in light of the FDA's recent decision to delay finalizing its proposed guidance on the issue. Our panelists will discuss how clinical genomics labs can and should ensure the analytical and clinical validity of their tests amid an uncertain regulatory climate. Webinar attendees will be able to ask questions of our panelists during a live Q&A session.


Enabling Clinical Genomics with Highly Multiplexed and Patient-Like Reference Materials

Industry expert Dr. Sandi Deans, Consultant Clinical Scientist and Director of UK National External Quality Assessment Service (UK NEQAS) for Molecular Genetics presents a case study of how a global external quality assessment (EQA) organization uses expert-designed, patient-like reference materials to ensure the accuracy and consistency of a clinical genomics application.



2016 AMP Workshop Recoding NGS-based Assay Validation and QC: A Complete Solution for the Clinical Sequencing Lab

Francine Blumental de Abreu, PhD will present how a lab can measurably improve and simplify their validations and daily QC using powerful reference materials, while also implementing easy-to-use lab QC software to track and report all key QC metrics.