Press Releases August 19, 2026 08:05 AM

MaxCyte launches CHANGE-seq-BE™ and ONE-seq-BE™ to strengthen off-target assessment for genome editing therapies

MaxCyte introduces advanced off-target nomination assays to enhance genome editing safety assessment

By Caleb Monroe
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MXCT

MaxCyte, Inc. has launched two new off-target nomination assays, CHANGE-seq-BE™ and ONE-seq-BE™, as part of its SeQure™ service platform. These assays provide sensitive and orthogonal methods to identify off-target sites in genome editing therapies involving adenine and cytosine base editors. This innovation supports therapeutic developers by enhancing off-target risk detection and aligning with FDA regulatory standards, thereby facilitating safer and more effective gene editing treatments.

MaxCyte launches CHANGE-seq-BE™ and ONE-seq-BE™ to strengthen off-target assessment for genome editing therapies
MXCT
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Key Points

  • MaxCyte introduced CHANGE-seq-BE™ and ONE-seq-BE™ assays that sensitize and broaden off-target site nomination for adenine and cytosine base editors.
  • The combined assays complement existing confirmation tools in SeQure™, offering comprehensive off-target risk evaluation for therapeutic developers.
  • This launch addresses regulatory expectations such as recent FDA guidance, emphasizing assay sensitivity and orthogonal approaches for genome editing safety.
  • Sector impact includes biotechnology, cell therapy development, genomic medicine, and regulatory compliance industries.

ROCKVILLE, Md., Aug. 19, 2026 (GLOBE NEWSWIRE) -- 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, today 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.”

For more information about MaxCyte’s SeQure services, please visit maxcyte.com/sequre.

About MaxCyte

At MaxCyte®, we are committed to building better cells together. As a leading cell-engineering company, we are driving the discovery, development and commercialization of next-generation cell therapies. Our 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, our 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, we've been advancing cell engineering, shaping the future of medicine. 

Learn more at maxcyte.com and follow us on LinkedIn and Bluesky.

MaxCyte Contacts:

Investor Relations
Gilmartin Group
Erik Abdow
[email protected]

Media Contact
Oak Street Communications
Kristen White
[email protected]
415.608.6060

Editorial contact for further information or follow-up:
Sarah Ballard at kdm communications limited, St Neots, UK
Tel. +44 (0)1480 405333   Fax: +44 (0)1480 477833
email [email protected]


Risks

  • Potential technological limitations in fully capturing all off-target effects may pose safety risks in clinical development of gene therapies.
  • Regulatory changes or evolving FDA requirements could impact demand or validation processes for MaxCyte's off-target assays.
  • Market competition from other genomic tools providers may challenge adoption or pricing power of MaxCyte's SeQure™ service.

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