Master file submission enables gene editing teams to streamline IND filings while protecting proprietary data

Cambridge, UK, 1st April 2026 - 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. 

The filing reflects increasing regulatory focus on comprehensive, cell-based assessment of on- and off-target effects in investigational new drug (IND) submissions, which INDUCE-seq® is designed to address. As expectations evolve, developers are under growing pressure to generate robust, genome-wide data early in development to support safety and decision-making. 

The INDUCE-seq® master file provides FDA reviewers with direct access to detailed technical, validation and performance data describing the platform, without requiring sponsors to include proprietary information in their own regulatory submissions. 

This enables gene editing teams to reference the platform through a Letter of Authorization (LOA), streamlining IND preparation while maintaining full protection of intellectual property. 

INDUCE-seq® is a cell-based, PCR-free platform designed to directly capture and map DNA breaks across the genome. The platform delivers quantitative, unbiased insight into both on- and off-target activity within days, supporting earlier, more confident decisions and reducing risk as programs progress toward the clinic. 

The master file includes comprehensive documentation covering platform design, analytical performance, software validation, and manufacturing and quality systems, providing a structured framework for regulatory review.  

Terry Pizzie, CEO, ���Ҵ�ý, said: “Regulatory expectations for genome-wide off-target analysis are evolving quickly, and teams need approaches that can stand up to that scrutiny. Too many programs are still relying on methods that are indirect, slow or difficult to scale, which creates risk later in development. 

By filing the INDUCE-seq® master file, we are making it significantly easier for our partners to incorporate high-quality, genome-wide break data into their regulatory strategy, without adding complexity to their submissions. It’s about enabling better decisions, earlier, and supporting programs as they move toward IND.” 

The master file has been formally submitted to the FDA and acknowledged, with an assigned reference number. It will be reviewed by the agency when referenced within a sponsor’s IND submission. 

As a living regulatory document, the master file will continue to be updated with additional data and validation, ensuring that sponsors referencing INDUCE-seq® benefit from the most current version during regulatory review. 

To learn more about ���Ҵ�ý and how INDUCE-seq® supports regulatory-ready genome-wide DNA break analysis, please visit: www.brokenstringbio.com