Comment from American Society of Gene & Cell Therapy
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Summary: The American Society of Gene & Cell Therapy (ASGCT) supports the draft guidance on NGS-based safety assessment of human genome editing products. They request additional clarity on assay performance principles, emerging editing modalities, and specific parameters for off-target and chromosomal integrity analysis to ensure consistent implementation across the industry.
Please see attached document for the American Society of Gene & Cell Therapy's comments. Thank you.