Abstract
At the 8th International Workshop on Genotoxicity Testing (IWGT) meeting
in Ottawa, August 2022, a plenary session was dedicated to the
genotoxicity risk evaluation of gene therapies, including insertional
oncogenesis and off-target genome editing. This brief communication
summarizes the topics of discussion and the main insights from the
speakers. Common themes included recommendations to conduct tailored
risk assessments based on a weight of evidence approach, to promote data
sharing, transparency, and cooperation between stakeholders, and to
develop state-of-the-art validated tests relevant to clinical scenarios.