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Analytical Validation of the Oncomine Pan-Cancer Cell-Free Assay

The Ion Torrent Oncomine Pan-Cancer Cell-Free Assay is designed to detect somatic DNA variants, copy number variants, and gene fusions in cell-free total nucleic acid (cfTNA) across 52 unique genes.

The genes included in the Oncomine Pan-Cancer Cell-Free Assay were selected based on curation of available peer-reviewed literature, clinical trial information, and NCCN guidelines. There are a wide range of gene alterations that impact therapy across selection indications, and molecular testing for these targets is important for both selection of appropriate targeted therapies and avoidance of therapies that are unlikely to provide clinical benefit. Thus, management of advanced solid tumors is becoming increasingly reliant on molecular testing of multiple genes from a single sample.

For example, the Oncomine Pan-Cancer Cell-Free Assay includes coverage of NCCN and European Society for Medical Oncology (ESMO guidelines–recommended genes for NSCLC—EGFR (including both EGFRTKI–sensitizing and acquired resistance mutations), ALK fusions, ROS1 fusions, and BRAF mutations. In addition, the assay enables highly sensitive detection of acquired resistance mechanisms to targeted therapies in NSCLC such as EGFR T790M mutations, kinase domain mutations in ALK, MET amplification and ERBB2 amplification.

Here we describe an analytical validation approach to assess the performance characteristics of the Oncomine Pan-Cancer Cell-Free Assay using both commercially available pre-characterized cell-free reference materials as well as clinical plasma samples from three solid tumor indications procured from a commercial biorepository.

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