Preclinical Genome Editing Risk Assessment Services

As FDA guidance on genome editing safety continues to develop, therapy developers face mounting pressure to generate data that is not only scientifically rigorous but structured for regulatory submission from the start. Off-target risk assessment now encompasses guide RNA design, variant-aware nomination, cell-based confirmation, and structural variant detection, each stage carrying its own evidentiary expectations.

The SeQure assay portfolio addresses these demands through orthogonal screening, nomination, and confirmation assays that span early discovery through IND-enabling studies. Results are delivered in filing-ready packages that include method justification, bioinformatics documentation, and functional annotations to support biological relevance assessment and risk stratification, in direct alignment with the April 2026 FDA draft guidance on NGS-based safety assessment.

Explore the full assay portfolio to see how each stage of off-target risk assessment is supported.