Analytical validation of StrandAdvantage solid tumor NGS test.

e12539 Background: Personalized cancer treatment can benefit from targeted deep-sequencingof multiple genes using NGS. The StrandAdvantage test panelassays 212 amplicons(48 genes) spanning hotspot mutations with highest relevance to the treatment of cancer. It is performed using the Illumina TSACP panel. We present results from the analytical validation of this panel performed in two different Strand laboratories located in Bangalore, India and Denver, U.S.A using DNA extractedfrom fresh tissue, FFPE, commercially available controls and patient samples. Methods: The analytical validation framework addresses accuracy, sensitivity and specificity, limit of detection, precision and reproducibility, using 12-15 independent sequencing runs of about 20 samples each performed in two separate laboratories (Bangalore and Denver). All of the above mentioned StrandAdvantage test performance characteristics were evaluated using DNA and FFPE reference standards from Horizon Diagnostics (Cambridge, UK), Jurkat and ...