APR 11, 2018 07:30 AM PDT

Keynote Presentation: A Regulatory Perspective on Molecular Diagnostic Devices

C.E. CREDITS: P.A.C.E. CE | Florida CE
  • Branch Chief, Molecular Pathology & Cytology Branch, Division of Molecular Genetics & Pathology, Office of In Vitro Diagnostics & Radiological Health, FDA
      Eunice Lee is currently Chief of the Molecular Pathology and Cytology Branch (MPCB) in the Office of In Vitro Diagnostics and Radiological Health in the Center for Devices and Radiological Health at the FDA. MPCB is responsible for reviewing regulatory submissions for a variety of in vitro diagnostic devices with oncology indications, including molecular and genomic assays, whole slide imaging systems, cytology collection devices, and companion diagnostics. Eunice graduated magna cum laude with an A.B. in biology and physics from Bryn Mawr College and a Ph.D. in biology from MIT. She completed fellowships at NIH and Stanford University and, prior to joining FDA, she worked at the National Cancer Institute.


    Advancements and innovation in in vitro diagnostic device (IVD) development are important for the success of personalized medicine. This is highlighted by the dramatic increase in the number of biomarker-targeted drug development programs since the first companion diagnostic and corresponding drug were approved in 1998. An overview of the current regulatory landscape for molecular diagnostics for oncology applications will be provided, with a focus on companion diagnostics and next generation sequencing (NGS)-based IVDs. Key issues and strategies impacting the regulatory framework for NGS assays for cancer indications will be discussed, and recent FDA clearances and approvals of diagnostic devices will serve as examples. 

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