Clinical genomics experts discuss overcoming QC and validation challenges

This report is based on a series of presentations by key opinion leaders and focuses on the validation and implementation of clinical next-generation sequencing assays. First, a round table of expert panelists provide an overview of their validation processes for laboratory-developed clinical genomics tests and specific validation guidelines. They identify specific recommendations, and discuss what labs can do today to prepare for the inevitability of future guidance. Also included are a series of three clinical genomics case studies focused on the following topics:

  • Development and validation of a cancer hotspot assay – Dr. Gregory J Tsongalis 
  • QC systems to comply with CAP, CLIA, & state regulatory guidelines – Dr. Robert Daber
  • Development and validation of clinical ctDNA cancer assays – Dr. Tony Godfrey 

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  • Improved performance and global standardization in the implementation of assays
  • Real-world examples of how some lab directors are bringing validated tests to the clinic
  • How clinical genomics labs can and should ensure the analytical and clinical validity of their tests

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