MaxCyte Launches CHANGE-seq-BE and ONE-seq-BE to Strengthen Off-Target Assessment for Base Editing Therapies
核心洞察
MaxCyte has launched CHANGE-seq-BE (搜索) and ONE-seq-BE (搜索) off-target nomination assays through its SeQure service to address a key gap in genome editing characterization.
The assays provide sensitive nomination of off-target sites for adenine and cytosine base editors (ABEs and CBEs), supporting safety assessment for therapeutic developers.
ONE-seq-BE (搜索) is the only nomination assay for base editors offering full visibility of population-specific genetic variants that may influence off-target activity.
MaxCyte, Inc. (搜索) (NASDAQ: MXCT), a cell-engineering focused company providing enabling platform technologies for next-generation cell therapeutics, announced the launch of the CHANGE-seq-BE (搜索) and ONE-seq-BE (搜索) 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).
The launch reflects a growing need for safety assessment strategies that account for the distinct mechanisms of action of base editors, which are creating new opportunities for therapeutic development while simultaneously requiring rigorous off-target evaluation.
Orthogonal Nomination Assays for Base Editors
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 (搜索) is described as a sensitive, unbiased biochemical off-target nomination method for base editors, while ONE-seq-BE (搜索) is positioned as 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.
Alignment with Evolving Regulatory Expectations
The launch is especially significant as developers work to align with evolving regulatory expectations, including recent FDA guidance on off-target editing and genome safety. The regulatory landscape places a growing emphasis on orthogonal assays, assay sensitivity, and modality-appropriate methods, all of which the new assays are designed to support.
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 (搜索) and ONE-seq-BE (搜索) 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."
About MaxCyte's Platform
MaxCyte's best-in-class Flow Electroporation technology and SeQure gene editing risk assessment services enable high-performance cell engineering and rigorous evaluation of editing outcomes, supporting confidence in therapeutic development. Supported by expert scientific, technical and regulatory guidance, the company's platform empowers researchers to engineer diverse cell types and payloads, accelerating the development of safe and effective treatments for human health. For more than 25 years, MaxCyte has advanced cell engineering, shaping the future of medicine.