Genecast Comprehensive is our proprietary multi-gene mutation detection kit designed for the comprehensive genomic profiling of tissue samples across a broad spectrum of solid tumors, utilizing capture-based targeted DNA and RNA NGS. It incorporates a panel of 769 target genes, including key oncogenes, tumor metabolic pathway genes, and immunerelated biomarkers, aligned with NCCN and CSCO guidelines, and includes important indicators such as MSI and TMB. The detection of gene mutations in the FFPE tissue samples provided by solid tumor patients is followed by the determination of MSI and TMB status. The comprehensive results could provide actionable molecular information to guide therapy selection, prognosis assessment and recurrence monitoring.

Genecast Comprehensive employs a parallel DNA and RNA co-detection strategy, with RNA analysis specifically enhancing the detection of gene fusions, that improves overall mutation detection rates. For gene mutation analysis, we have developed bioinformatics algorithms capable of operating with matched normal samples or independently on tumor tissue or plasma liquid biopsy samples. These algorithms not only enable highly accurate detection of somatic mutations but also estimate the likelihood that a specific pathogenic mutation is of germline origin. This capability is particularly valuable in clinical settings where matched white blood cell samples are unavailable. Additionally, the algorithm supports biomarker evaluation and identification of chemotherapy-associated loci. Analytical results are linked to a continuously updated evidence collection, offering insights into potential therapeutic options and relevant ongoing clinical trials, thereby broadening its clinical application value.

We obtained CE marking for Genecast Comprehensive in March 2022.