Development and Validation of StrataNGS, a Multiplex PCR, Semiconductor Sequencing-Based Comprehensive Genomic Profiling Test

Despite widespread use in targeted tumor testing, multiplex PCR/semiconductor (Ion Torrent) sequencing-based assessment of all comprehensive genomic profiling (CGP) variant classes has been limited. Here we describe the development and validation of StrataNGS, a 429 gene, multiplex PCR/semiconductor sequencing-based CGP laboratory developed test performed on co-isolated DNA and RNA from FFPE tumor specimens with ≥ 2mm2 tumor surface area. Validation was performed in accordance with MolDX CGP validation guidelines using 1,986 clinical FFPE samples and an in-house developed optimized bioinformatics pipeline.

Source: Journal of Molecular Diagnostics - August 25, 2021 Category: Pathology Authors: Scott A. Tomlins, Daniel H. Hovelson, Paul Harms, Stephanie Drewery, Jayson Falkner, Andrew Fischer, Jennifer Hipp, Kat Kwiatkowski, Lorena Lazo de la Vega, Khalis Mitchell, Travis Reeder, Javed Siddiqui, Hana Vakil, D. Bryan Johnson, Daniel R. Rhodes Source Type: research