SeQure Dx was founded to alleviate for biopharma partners the extensive infrastructure required to identify, manage and mitigate the off-target risks throughout the gene editing therapeutic discovery, development and commercialization lifecycle.
Please contact firstname.lastname@example.org for all partnering inquiries.
Partnership with SeQure Dx at the discovery-stage of therapeutic development culminates in a comprehensive off-target package required for IND filing that meets the FDA’s latest guidance for therapy development in the gene editing space.
Our gene editing technology-agnostic platform will provide our partners with the ability to:
- Optimize gene editing components
- Perform required preclinical safety assessments
- Define and characterize off-target activity, even in rare sub-populations and underrepresented groups
- Provide clinical decision-making risk / benefit profile to advance programs
We do this by using a diverse genomic database coupled with our population-based in silico and in vitro off-target predictive assay and then confirmed with in vitro and ex vivo confirmation assays with additional orthogonal validation, culminating in a detailed analytical data report.
Partnering with SeQure Dx during the clinical development stage will provide our partners with tools to manage patient risk for both enrollment and during follow-up, improving time and economic efficiency.
During the clinical development phase our portfolio will provide cost and time efficiencies by:
- Launching and executing clinical trials via patient pre-enrollment risk screening and follow-up risk monitoring
- Creating a coordinated regulatory plan that leverages the appropriate data generated throughout the clinical trial
SeQure Dx comprehensively manages the post-approval diagnostic requirements to ensure and maintain broad access to the companion gene editing therapy.
Post therapy approval, SeQure Dx enables patient access by providing our partners with:
- Patient education and genetic counseling
- Physician education
- Clinical decision support via patient pre-treatment risk screening
- Post-treatment long term follow-up and risk monitoring