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.
At KROMATID, we spent 2025 partnering with innovators across the CGT landscape, helping developers interrogate their edited cells at a level of resolution that conventional bulk assays can’t reach. As we reflect on the year, several takeaways emerged that are already reshaping expectations for 2026.
Key Takeaways From 2025
1. Genomic Stability Became a Non-Negotiable Metric
Therapies once evaluated primarily on efficacy now face equally rigorous scrutiny of genomic integrity. Developers increasingly sought tools to detect integration location, copy number burden, and unintended structural changes, especially as cell engineering technologies increased in breadth and complexity.
2. Bulk Approaches Hit Their Analytical Limits
Sequencing and digital PCR remained essential, but developers recognized their constraints. Bulk-readouts obscure cell-to-cell heterogeneity, leaving critical questions unanswered:
Are genomic edits evenly distributed? Are risky clones emerging? What rare structural events are escaping detection?
2025 was the year the industry began acknowledging that averages can be misleading—sometimes dangerously so.
3. Single-Cell Resolution Went From Novelty to Necessity
As more companies moved toward allogeneic and off-the-shelf designs, the need for controlled genomic integration intensified. High-resolution, single-cell cytogenetic tools - like KROMASURE - became integral for understanding transgene placement, copy number distribution, and clonal dynamics across thousands of individual cells.
Looking Ahead: What We Expect in 2026
1. Regulators Will Demand Higher Sensitivity, Single-Cell Data
In 2026, we anticipate a decisive shift: the FDA and global regulatory agencies will increasingly require single-cell data to demonstrate genomic stability in cell and gene therapies. Developers will no longer be able to rely solely on bulk sequencing metrics. Instead, they will need to show:
- If structural variants co-localize with therapeutic edits
- Whether high-burden outlier populations are expanding
- Where transgene integrations occurred
- How many transgene or exogenous cargo copies exist per cell
Single-cell evidence will transition from a competitive advantage to a regulatory prerequisite.
2. Clonal Architecture Will Become a Safety Readout
Clonal dominance - once primarily a manufacturing concern - will emerge as a long-term clinical safety parameter. Understanding how individual genomic events propagate across thousands of cells will directly influence product release decisions.
3. High-Throughput Cytogenetics Will Move Upstream
Analyses once reserved for IND-enabling studies will migrate earlier into discovery and process development. The industry will prioritize genomic design space, not just biological performance, reducing costly late-stage failures.
The Takeaway
2025 taught us that the future of cell and gene therapy hinges on more than editing efficiency, it depends on understanding the genomic landscape that cell modifications create. As we step into 2026, the industry is aligning around a clear truth:
Genomic stability must be proven, not assumed. And proving it requires data at the level where biology actually operates, the single cell.
At KROMATID, we are proud to support therapeutic developers with the high-resolution cytogenetic tools needed to meet evolving regulatory expectations and to build therapies that are not only innovative, but safe, durable, and ready for the clinic.