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Noninvasive Personalization of Lung Cancer Therapy Using a New, Clinical-Grade Assay for Plasma-Based Measurement and Monitoring of Tumor Genotype
Technical Report,30 Sep 2014,29 Sep 2016
Dana-Farber Cancer Institute Boston United States
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The overarching aim of this project was to perform blinded prospective validation of a new assay for noninvasive and quantitative genotyping of cell-free plasma DNA cfDNA using droplet digital PCR ddPCR. In this project we launched a prospective correlative study tovalidate the accuracy of this assay for detection of EGFR and KRAS mutations in patients with NSCLC, to optimize handling conditions to maximize the reliability of results, and to understand response of plasma cfDNA on therapy. We successfully validated the assay with 100specificity for key EGFR and KRAS driver mutations. Assay sensitivity was 64-83, and improved with a greater number of sites of metastatic disease. Serial plasma assessment revealed dramatic early reductions in plasma mutation levels, which predicted for a response on imaging. Importantly, one of the most important successes of this project was using the validation of this assay to lay the groundwork for my career development as the awardee, who has received grant funding to pursue multiple follow-up projects using this technology.
APPROVED FOR PUBLIC RELEASE