DIA 2017 Annual Meeting: Regulatory Challenges with Next Generation Sequencing

Chicago, IL

Kim Tyrrell-Knott, Member of the Firm, will moderate a panel discussion, "Regulatory Challenges with Next Generation Sequencing," at the DIA 2017 Annual Meeting.

The high interest and rapid uptake of next-generation sequencing in the clinic speaks to the promise of this technology as a valuable adjunct for optimizing therapeutic treatment, yet much of this promise remains untapped. The challenge associated with establishing a regulatory framework stems from the lack of available standards to help establish the safety and effectiveness of this technology, and from the lack of high quality, public databases with data curated from validated methods for use in clinical decision making.

Learning objectives:

  • Understand recent FDA draft guidance regarding potential regulatory classification and pathways for genetic tests
  • Understand the use of public genetic variant databases to support clinical validity
  • Explore the impact recent FDA next gen sequencing proposals on industry in the context of the changing regulatory environment for IVDs and lab developed tests (LDTs)

For more information, visit DIAglobal.org.