Next generation sequencing (NGS) technologies are rapidly evolving and transforming oncology at an astonishing rate. One gene panel can now generate a wealth of mutation information for common cancers. As these solutions move from research to clinical use they present challenges and opportunies for the FDA in developing standard and guidelines for clinical laboratories performing NGS for assessment of targeted gene panels.

In this 45-minute webinar learn about:
REGULATORY FRAMEWORK

  • NGS oncology panels as LDTs
  • FDA Framework: the past, present and future

SEQUENCING STANDARDS

  • Sequencing standards in NGS oncology panels
  • Types of sequencing standards
  • FDA framework for sequencing standards