MaxCyte, Inc. (NASDAQ: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell therapeutics, announced the launch of the CHANGE-seq-BE™ and ONE-seq-BE™ off-target nomination assays. Available through MaxCyte’s SeQure™ service, these assays address a key gap in genome editing characterization by offering sensitive nomination of off-target sites for adenine and cytosine base editors (ABEs and CBEs).

SeQure provides integrated reporting across orthogonal nomination assays, enabling therapeutic developers to identify overlapping and distinct nominated sites and to prioritize regions for confirmation assays. CHANGE-seq-BE is a sensitive, unbiased biochemical off-target nomination method for base editors, and ONE-seq-BE is the only nomination assay for base editors that provides full visibility of population-specific genetic variants that may impact off-target activity.

By combining these two assays, MaxCyte is uniquely positioned as a single-source provider of orthogonal nomination assays for base editors. Together with SeQure’s existing confirmation assays for quantitative off-target editing measurement and structural variation detection, therapeutic developers can confidently assess off-target risks in the relevant cell and tissue context. This is especially important as developers work to align with evolving regulatory expectations – including recent FDA guidance on off-target editing and genome safety – with a growing emphasis on orthogonal assays, assay sensitivity, and modality-appropriate methods.

Maher Masoud, President and CEO at MaxCyte, commented: “Base editors are creating new opportunities for therapeutic development, while also requiring safety assessment strategies that reflect their mechanisms of action. The addition of CHANGE-seq-BE and ONE-seq-BE to our SeQure services gives developers access to sensitive, orthogonal off-target assessment capabilities that can help them to better understand and mitigate off-target risk, building stronger data packages for clinical development.”