Partnering for Therapeutic Discovery

Our partnerships are powered by the NoteSeQ and ScopeSeQ Platforms

Our Value

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.

Learn more about our NoteSeQ and ScopeSeQ platforms

Discovery

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.

Development

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

Commercial

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