A multi-site study published in Gene Therapy evaluates two streamlined assays—SACF and GILA—designed to improve how teams detect unintended transformation risks from CRISPR/Cas9-edited cell therapy candidates in vitro. The work addresses a core gene-editing translational barrier: on-target edits can look clean while rare off-target cellular changes emerge that may alter growth behavior. By standardizing and improving transformation readouts using reduced and more efficient assay workflows, the study aims to strengthen candidate de-risking before moving into more resource-intensive development stages.
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