SAFER Detection™
Confirmation Assay
SeQure Dx's SAFER Detection assay confirms on-target, off-target, and homology-mediated structural rearrangements resulting from gene editing. It also profiles integration sites and determines vector copy number following viral transduction. Our comprehensive biological impact analysis report addresses FDA expectations for structural rearrangement data, helping to mitigate risks of IND filing delays and enhancing the safety profile of your cell and gene therapy development programs.
SAFER Detection Overview
SAFER Detection
High sensitivity confirmation of structural rearrangements in your cell type of interest post-editing. NGS interrogation allows for resolution down to exact genomic coordinates. Additionally capable of detecting gene insertions from viral-mediated cell engineering workflows.
Confirmation
Verifies structural rearrangements
- Sensitive detection
- Relevant cell types
- On-target ,off-target, and homology-mediated rearrangements
Cellular Editing Assessment
IND Filings
- Biologic impact assessment
- GLP
Related Confirmation Assay
Discover a comprehensive suite of assays spanning from early discovery through pre-clinical and clinical development.
