As gene therapy, cell therapy, nucleic acid drugs (ASO/siRNA), and genetically modified microorganism (GMM) products continue to advance, safety assessment has become essential to successful clinical translation. GeneRulor, China's first comprehensive safety evaluation service platform, has established a complete assessment framework covering multiple innovative product categories. For gene-editing products, we provide whole-genome off-target detection, chromosomal structural abnormality analysis, and viral vector integration site identification. For nucleic acid drugs (ASO/siRNA), we offer target design optimization, off-target prediction, and RNA-seq validation. For live biotherapeutic products (GMM), our services include recipient microorganism characterization, whole-genome sequencing, exogenous gene safety bioinformatics analysis, and product residual detection. Additional capabilities encompass epigenomics analysis, single-cell sequencing, and cfDNA dynamic monitoring, providing full-lifecycle coverage for R&D needs. To date, GeneRulor has deployed 50+ validated detection solutions with customizable service options, backed by extensive FDA/CDE regulatory and submission expertise — supporting 10 IND approvals in 2025 (US & China) — committed to delivering reliable safety assessment for biopharmaceutical innovators.
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stChina's First Comprehensive Safety Evaluation Platform
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+Validated Off-Target Detection Solutions
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%IND Submission Success Rate to Date
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个IND Approvals Achieved in 2025
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