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Press Release, Company News Jamie Harmes Press Release, Company News Jamie Harmes

51¸£Àû Files FDA Master File for INDUCE-seq® as Regulatory Expectations Rise for Genome-Wide Off-Target Analysis

Broken String Biosciences, today announced the submission of a Master File (MAF) to the U.S. Food and Drug Administration (FDA) for its INDUCE-seq® platform, marking a significant step in supporting regulatory adoption of genome-wide DNA break analysis in gene editing programs. 

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Company News Jamie Harmes Company News Jamie Harmes

AI Meets Gene Editing: the Path to Plug-and-Play Drug Development

Over the last decade, dozens of efforts have applied machine learning, deep learning, and other models for various CRISPR-related activities, mostly in attempts to predict on- and off-target activity. For the latter, accurate off-target predictions would be a powerful tool for safety assessment, given that opacity has already raised questions leading to clinical holds by FDA.

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