On- and off-target gene editing assessment services

Patient safety is critical for regulatory success. SeQure Dx specializes in off-target analysis services to reduce risk and improve the safety profile of gene-edited cell and gene therapies. Our advanced assays ensure precise editing confirmation and thorough risk assessment across viral and non-viral editing platforms. By addressing potential risks early, we help developers make data-driven decisions, reduce costs, and create safer, more effective therapies—accelerating their path to patients.

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Comprehensive suite of assays from discovery to IND

Understanding the off-target editing profile of cell and gene therapy programs earlier in the discovery process increases the likelihood of success and decreases the risk of significant unexpected costs, delays and program halts. SeQure Dx offers Screening, Nomination and Confirmation assays to speed your way to the clinic with safer therapies.

SeQure-Assay Summary (1)
Keith Joung

J. Keith Joung, MD, PhD
Scientific Founder

History of Secure Dx

SeQure Dx began with a mission to reduce the risk of cell therapy development and manufacturing, ensuring safer therapies reach patients faster. By creating leading on-target and off-target assessment assays, we empower precision medicine advancements and remain committed to transforming the future of healthcare.

The SeQure Dx assay portfolio aligns with most recent FDA guidance for gene edited therapies.

FDA-table

FDA guidance that is being referred to can be found here.

Featured Resources

ONE-seq for Variant-Aware Therapeutic Guide Selection-One-seq incorporates global human genetic diversity
Poster
ONE-seq for Variant-Aware Therapeutic Guide Selection
SAFER Detection for Efficient Interrogation of DNA Rearrangements in Gene-Edited Human Cells-Figure 2D
Poster
SAFER Detection for Efficient Interrogation of DNA Rearrangements in Gene-Edited Human Cells
Guide Profiler-A Genetic Variant-Aware Computational Tool for Improved Guide RNA Selection for CRISPR-based Therapeutic Applications-Figure 1G
Poster
Guide Profiler: A Genetic Variant-Aware Computational Tool for Improved Guide RNA Selection for CRISPR-based Therapeutic Applications
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