Insertional Mutagenesis Risk

For decades, cytogenetics has played a critical role in therapy development. It has helped us see when genomes are altered, unstable, or outright broken. But as cell and gene therapies become more sophisticated - and the margin for error shrinks - seeing is no longer enough.

Hematopoietic stem cells (HSCs) sit at the foundation of many cell and gene therapy programs. Whether used in autologous or allogeneic settings, ex vivo gene editing or viral transduction, HSCs are often treated as a standardized input—assumed to be equivalent as long as basic identity, viability, and purity criteria are met.

Despite numerous challenges, the cell and gene therapy (CGT) sector has never moved faster. In 2025, we saw breakthroughs in precision editing, rapid scale-up of manufacturing platforms, and renewed investor attention on therapies with clear clinical differentiation. But alongside the scientific momentum, one theme stood out more than any other: genomic stability is now a defining hallmark for safety, reproducibility, and regulatory confidence.