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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
In Vivo CAR Beyond Treating Cancer: From Immune Reset to a New Measurement Challenge

In Vivo CAR Beyond Treating Cancer: From Immune Reset to a New Measurement Challenge

By Dr. Elizabeth Yan Zhang, CMQ/OE, MBA, PhD, Founder and CEO, GeneGoCell on August 24, 2026

Explore how CAR therapy is moving beyond cancer toward autoimmune immune reset and in vivo engineering, and why analytical characterization must evolve with it.
in vivo CARCAR cell therapyGenome Editing VerificationCell and Gene TherapyCAR cell therapy beyond cancer
Detection and Quantification of Integration using Genome Editing Verification (GEV℠) Integration (G-Int℠) Workflow

Detection and Quantification of Integration using Genome Editing Verification (GEV℠) Integration (G-Int℠) Workflow

By Dr. Aaron Zhang-Chen, CQA, PhD on August 17, 2026

Explore GeneGoCell’s G-Int℠ NGS workflows for integration site identification, integration efficiency analysis, and transgene integrity analysis after genome editing.
Genome Editing VerificationG-LMP℠G-Int℠GEV℠Genome Editing Integration AnalysisIntegration Site AnalysisTransgene IntegrityCell and Gene Therapy