Use of the GUARDANT360 noninvasive tumor sequencing assay on 300 patients across colorectal, melanoma, lung, breast, and prostate cancers and its clinical utility.

2014 
e22041 Background: Analysis of genomic alterations in advanced malignant disease is quickly becoming the standard of care in oncology. Biopsies are risky, often costly and may not capture genetic changes that can emerge over time or in response to therapy. In contrast, GUARDANT360, a blood-based liquid biopsy approach that analyzes circulating tumor DNA (ctDNA), offers a simple and comprehensive tool for real-time tumor genetic profiling in advanced refractory cancer patients. Methods: We studied the performance of GUARDANT360 in five prevalent cancers: colorectal, melanoma, lung, breast, and prostate. Over 500 plasma samples and 100 matched tumors from a total of 300 unique patients were analyzed using GUARDANT360, a single-molecule next-generation digital sequencing assay with ability to detect somatic mutations and copy number variations with exquisite sensitivity. The assay covers sequences across a total of 54 actionable genes covering approximately 80 kbps. Select patients were treated on the basis ...
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