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What Must Be Measured, and What Can Be Shared: NGS, prior knowledge, and genome-editing safety in three 2026 FDA publications

What Must Be Measured, and What Can Be Shared: NGS, prior knowledge, and genome-editing safety in three 2026 FDA publications

By Dr. Aaron Zhang-Chen, CQA, PhD on August 31, 2026

What do three 2026 FDA guidance/recommendation mean for genome editing? Learn what NGS safety data should be measured, what prior knowledge can be reused, and when.
Genome Editing SafetyGenome Editing VerificationOff-target AnalysisChromosomal Translocation AnalysisCell and Gene TherapyFDA Gene Therapy Guidance
Identifying and Quantifying Structural Variants using Genome Editing Verification (GEV℠) Translocation (G-Trans℠) Workflow

Identifying and Quantifying Structural Variants using Genome Editing Verification (GEV℠) Translocation (G-Trans℠) Workflow

By Dr. Aaron Zhang-Chen, CQA, PhD on August 10, 2026

Learn how G-Trans uses UMI-enabled, ligation-mediated NGS to identify and quantify genome-wide chromosomal translocations after genome editing.
Genome Editing VerificationG-LMP℠G-Trans℠GEV℠Genome Editing Translocation AnalysisChromosomal Translocation Analysis