Base editing technology enables precise single-base conversion without double-strand breaks, covering over 60% of known pathogenic point mutations. However, its unique dual off-target mechanism presents safety challenges far exceeding traditional CRISPR tools.
Base editing technology achieves precise single-base conversion without double-strand breaks, showing tremendous potential in genetic disease and cancer treatment. However, its unique off-target mechanisms present unprecedented safety assessment challenges.
For the unique off-target mechanisms of CBE and ABE, we have constructed a multi-level, dual-dimensional detection strategy forming a complete evidence chain meeting regulatory requirements.
Uses dedicated technologies for CBE and ABE respectively: Detect-seq specifically captures deoxyuridine (dU) intermediates for CBE; Ino-seq tracks deoxyinosine (dI) products for ABE. Combined with 100X WGS and specialized software prediction for comprehensive off-target coverage.
Sequencing Depth: ≥100X WGSCaptures random RNA editing events triggered by base editor deaminases through specialized RNA-seq analysis workflows. Distinguishes editing events in Alu repeat and non-repeat regions, comprehensively annotating 12 base editing types to fill DNA detection blind spots.
Combines Targeted Enrichment Sequencing (TES) with deep amplicon sequencing for stepwise validation. Introduces UMI technology to eliminate PCR amplification bias, enabling high-sensitivity quantitative validation of candidate off-target sites.
Validation Sensitivity: 0.01%We possess the most complete base editing safety assessment technology chain in China, providing dedicated solutions for the unique mechanisms of CBE and ABE.
One of the few domestic enterprises simultaneously providing CBE/ABE dedicated off-target detection, whole genome sequencing, transcriptome RNA off-target detection, and comprehensive validation services. Standardized ISO 9001/CNAS processes ensure accurate and reliable results.
Independently established Detect-seq (CBE-specific) and Ino-seq (ABE-specific) detection platforms. Comprehensively covers all off-target types including sgRNA-dependent, independent, protospacer-external, and target strand editing.
Successfully served multiple leading CGT enterprises with deep understanding of IND filing regulatory requirements. We provide not only testing data but also complete regulatory submission packages meeting global standards.
Supports both full-process IND packages and individual services with customized solutions tailored to client needs and budgets. Dedicated one-on-one project managers ensure efficient project progress and on-time delivery.
We offer two service models to meet the needs of different clients at various development stages.
Clients preparing for IND filing requiring complete safety assessment data
Deliverables: Complete IND-compliant testing report + expert interpretation + regulatory support
Clients with specific testing needs requiring flexible combinations
Deliverables: Single or multiple testing data reports + technical support
Our one-stop solution significantly reduces your project cost and timeline while improving regulatory submission success rates.
Tell us about your editor type (CBE/ABE) and development stage. We will provide a customized base editing safety assessment plan and timeline compliant with FDA/CDE requirements.
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