Bringing a new drug to market is a complex, multi-year endeavor filled with regulatory hurdles, and one of the earliest and most critical is the Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). A successful IND submission opens the door to clinical trials, making it a pivotal milestone for any pharmaceutical or biotech company. For developers of gene editing therapies, demonstrating genomic integrity and structural safety is essential — and that's where KROMATID comes in.
Structural Clarity for Regulatory Confidence
At the heart of many gene therapies is genome engineering, which introduces the risk of unintended structural variations (SVs) like chromosomal translocations, inversions, or large deletions and duplications. These events can have significant safety implications, and the FDA expects sponsors to characterize and mitigate such risks in IND submissions.
KROMATID’s proprietary structural genomics platform offers unmatched sensitivity and resolution for detecting on-target and off-target SVs that other technologies, like short-read sequencing or karyotyping, can miss. Our technology delivers single-cell, whole-genome structural variation analysis, giving regulators the confidence that your therapy is built on a genomically stable foundation.
How KROMATID Enhances IND Submissions
✅ Comprehensive Structural Variation Profiling
KROMATID provides a clear, cell-by-cell view of structural rearrangements at a resolution down to a few kilobases. Our assays can:
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Detect translocations
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Identify inversions, duplications, and deletions
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Differentiate between clonal and random events
This level of detail allows you to thoroughly characterize your gene editing outcome — a critical requirement in any IND package.
✅ Orthogonal Validation for Genome Editing Safety
The FDA encourages the use of orthogonal methods to validate genome editing results. KROMATID’s assays are highly complementary to sequencing-based approaches, making them an ideal orthogonal method to confirm:
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Absence of unexpected rearrangements
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Integrity of engineered loci
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Specificity of CRISPR or other nuclease systems
By integrating KROMATID’s data into your submission, you strengthen your safety case and demonstrate rigorous assay validation.
✅ Rapid Turnaround for Time-Sensitive Milestones
We understand that timelines are tight during preclinical development. KROMATID’s workflows are designed for rapid deployment and data delivery, helping you stay on track for your IND filing and avoid costly delays.
✅ Expert Support for Regulatory Documentation
Our experienced scientific team works closely with you to generate publication-ready figures, data summaries, and methods descriptions tailored for FDA submissions. Whether you need help interpreting results or preparing the regulatory narrative, we’re here to support your team.
Build a Stronger IND Submission with KROMATID
From discovery through IND submission, structural genomic integrity is a key pillar of gene therapy development. KROMATID’s platform enables unparalleled insight into the structural consequences of genome engineering, helping you deliver the comprehensive safety data the FDA expects.
Let’s de-risk your IND submission — contact us to learn how KROMATID can support your gene therapy pipeline.