For iPSC-derived cell products, after detection of all types of SNV, InDel, CNV and SV variants by WES and WGS, the professional medical genetics scientists will assess the risk of tumorigenicity and pathogenicity of the mutations based on the authoritative mutation database and analysis process in line with the ACMG guidelines and provide a comprehensive test analysis report accordingly.
We provide whole genome sequencing and PCR amplicon sequencing for detection of on-target and off-target gene editing events, suitable for samples at various stages of research and development, in vitro and in vivo efficacy and toxicology samples, cell banks, cell products and clinical samples. For off-target mutations detected, we provide a mutation interpretation report, such as tumorigenicity and pathogenicity, based on the mutation database in accordance with the ACMG guidelines.
We use single cell sequencing to study different cell populations in the cell products, analyze cell population composition,differentiation characteristics, stem cell residues, and impurity cell types, and provide a comprehensive assessment of the quality characteristics and safety of the cell products.