Technical validation of novel 325 RNA predictive biomarkers using gene expression data generated by Nanostring n-counter and Affymetrix microarray

With new developments of oncology drug combinations and targeted treatments, the ability to stratify categories of patient populations and to develop companion diagnostics has become increasingly important. A panel of 325 RNA-biomarkers was selected based on cancer-related biological processes of healthy cells and gene expression changes over time during non-malignant epithelial cell organization. This “cancer in reverse” approach in combination with empirically derived algorithms resulted in a panel of biomarkers having little overlap with 9 other widely-used commercial gene panels. A study was conducted to technically validate the 325 RNA-biomarkers with multiple days and users and compare gene expression profiles side-by-side using two technology platforms to address the reproducibility of the assay. A Pearson correlation showed reproducibility between sites with r=0.995 for Affymetrix and r=0.999 for Nanostring. The 325 gene assay was independently validated in multiple laboratories, multiple users, in multiple days with high reproducibility.  The study supports the use of the 325 gene assay for oncology drug discovery and development

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2018-04-25T03:51:08+00:00