NOV 09, 2017 1:30 PM PST

The Development and Commercialization of Robust Circulating DNA and RNA Tests

Speaker
  • Director, Molecular Development at Biodesix
    Biography
      Dr. Mellert is a Director within the Biodesix Development group. She has a background in molecular cancer biology and experience leading teams in the development and commercialization of blood-based diagnostic tests under CAP/CLIA and NYS CLEP. Dr. Mellert has played a leading role in the support of GeneStrat including the launch of EML4-ALK, ROS1 and RET fusion tests out of blood. She continues to focus her efforts on bringing relevant and actionable information to physicians in the academic and community setting. Dr. Mellert received her Ph.D from the University of Pennsylvania and post-doctoral training at the University of Colorado. She has received a number of awards including the American Cancer Society Post-doctoral fellowship.

    Abstract

    The GeneStrat® Genomic Test is a blood-based series of ddPCR tests for DNA (EGFR, KRAS, BRAF) and multiplexed assays for RNA variants (EML4-ALK, ROS1, RET).  In this report we will update on test and specimen collection kit design considerations, feasibility and product development studies. We will report on post-launch test performance using the included nucleic acid preserving blood collection tubes.


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