Gene Editing Analysis Solutions
Prediction of off-target editing to quality control testing of clinical candidates.
An IND-Enabling and Clinical Batch Testing Assay Package
SeQure Dx’s NoteSeQ™ and ScopeSeQ™ plus KromaTiD’s dGH™ platforms offer the only comprehensive analytical approach for your editing system optimization, genotox assessments, IND-enabling studies and clinical batch testing. Throughout the journey, KromaTiD and SeQure Dx will support all your R&D and regulatory filing needs.
We acknowledge the pressing need for a more efficient and comprehensive solution to your program’s pipeline. That’s why we’re committed to providing a streamlined approach for your off-target analysis and donor qualification using our combined assays. Our IND-enabling off-target safety package is designed to encompass the full nomination and confirmation analysis process, offering your company the flexibility to integrate this solution at any stage of your development.
- NoteSeQ: Guide Selection, Off-target Assessment, and IND Service – Leveraging the ONE-seq assay to biochemically nominate and illuminate off-target risks and develop mitigation strategies with greater sensitivity and breadth across populations than any other assay.
- ScopeSeQ: Cellular Editing System Assessments, and IND Services – to confirm and verify off-target gene editing findings.
- dGH in-Site™: Direct, single-cell visualization of the structure of on- and off-target DNA edit sites and mapping of transgene insertions anywhere in the genome.
- dGH SCREEN™: Single cell, unbiased and ultra-high-resolution mapping of structural variants as small as 5 kb.
- Genomic Integrity G-Band Karyotyping: Confirmatory mapping of low prevalence, edit-associated chromosomal structural variation, identification of sub-clonal cell populations and monitoring of cell and gene therapy batch stability.
No matter where your company stands in its development journey our approach is adaptable, ensuring you receive the level of support that aligns with your specific requirements.
- Guide RNA – De novo selection or optimization
- Editing system evaluation
- Donor qualification for allogeneic cellular therapy products
- Final product editing evaluation
- Comprehensive IND-enabling safety package creation
How We Work Together
SeQure Dx will meet all your nomination and prediction needs using ONE-seq and GUIDE-seq.
SeQure Dx will provide KromaTiD with lists of potentially genotoxic or high prevalence cleavage sites.
KromaTiD will design custom dGH in-Site™ assays to measure real edit-associated variants in many single cells and map your transgene insertions.
From R&D phase through your IND filing, KromaTiD and SeQure Dx will perform your verification assays.
KromaTiD and SeQure Dx can qualify any of your verification assays as GLP QC tests, including cellular editing confirmation with SAFER detection.
Inquire today about how KromaTID and SeQure Dx comprehensive assay package can get you ready for your IND!