The Validation of the FDA Approved OncoReveal CDx Pan-Cancer Solid Tumor IVD

Pillar Biosciences oncoReveal CDx pan-cancer solid tumor IVD kit is an FDA PMA approved for general tumor profiling for 22 clinically relevant genes across all solid tumors, including CDx claims for KRAS in CRC and EGFR in NSCLC. This IVD kit has a rapid single-day workflow that can easily be performed by any CLIA/CAP laboratory enabled with an Illumina MiSeq Dx. This workshop will provide a detailed technical overview of this new IVD assay, review the simple NGS workflow, and discuss the analytical and clinical validation data in support of Pillar's FDA approval. We will also review Molecular Pathology Laboratory Network, Inc. (MPLN) experience and data associated with verifying this IVD for clinical and biopharma use.