JUL 29, 2026 · JOURNAL ARTICLE
SACF and GILA for in vitro transformation assessment of CRISPR/Cas9-edited cell therapy candidates: a multi-site study
Gene Therapy
Multi-site assay validation study establishing reproducibility of in vitro transformation assays in a single cell line model; supports exploratory use but does not yet establish clinical utility or predict in vivo tumorigenicity risk in actual CRISPR therapies.
Reported
Limit of detection (LOD)0.8%
GILA plateauing concentration thr…>12.5%
Number of laboratories4