The Simple Verifiation in a Molecular Pathology Lab of the FDA Approved oncoReveal CDx Pan-Cancer Solid Tumor IVD Assay
Event Name: AMP 2024
TBC
Clinical Verification of an FDA-Approved NGS Solid Tumor IVD Assay
Analytical Validation of oncoReveal CDx as a FDA approved, Pan-Cancer Solid Tumor IVD Assay
oncoReveal® CDx is the first FDA-approved distributed, kit-based NGS assay for both companion diagnostic use and pan-cancer tumor profiling, covering more than 3,600 SNV and indel targets across 22 genes from FFPE DNA on the Illumina MiSeqDx. Validation spanned 10 tumor types and addressed DNA input range, minimum tumor content, necrosis tolerance, limit of detection by probit analysis, accuracy against two externally validated NGS comparators, and a three-site reproducibility study. The assay achieved 100% positive and 99.996% negative percent agreement at 30 ng input, with valid results down to 3.3% tumor content.