The KROMASURE™ Platform

KROMATID provides advanced genomic integrity testing services for cell and gene therapy developers. Our proprietary KROMASURE™ platform delivers single-cell, chromosome-level analysis to detect structural genomic changes that may be missed by population-based methods.

Our portfolio includes:

• KROMASURE™ Screen for comprehensive genome-wide assessment of structural rearrangements.
• KROMASURE™ PinPoint for targeted analysis of vector integration sites, insertional copy number, and genomic integrity.
• KROMASURE™ InSite for locus-specific evaluation of targeted genome edits and insertions.
• KROMASURE™ KBAND for high-resolution chromosome analysis with significantly greater cell throughput than traditional karyotyping.

In addition to our testing services, KROMATID partners with customers throughout the development lifecycle—from early research and process optimization through IND-enabling studies, manufacturing support, and post-market applications—to generate actionable genomic integrity data that helps de-risk cell and gene therapy programs.

Yes. KROMATID works closely with customers to develop testing strategies tailored to the unique needs of their cell and gene therapy programs. Whether you require a customized study design, targeted genomic analysis, specific reporting formats, or support for a particular stage of development, our scientific team collaborates with you to deliver meaningful, actionable results.

Our flexible KROMASURE™ platform can be adapted to a wide range of cell types, gene editing technologies, viral and non-viral delivery methods, and therapeutic applications, helping ensure the data generated aligns with your development and regulatory objectives.

That depends, on which solution or solutions we are doing, and how many samples we are analyzing. Before every project we do give a delivery date, so that you know what to expect. 

KROMATID is committed to delivering high-quality, reliable data through a robust quality management system and rigorous quality assurance processes. We support studies across the development lifecycle, including Research Use Only (RUO), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP) testing, with quality systems designed to meet the requirements of each environment.

Our quality processes include validated workflows, comprehensive documentation, equipment qualification and maintenance, method controls, data review, and independent quality oversight. Every project follows standardized procedures to ensure data integrity, traceability, reproducibility, and compliance with applicable regulatory and customer requirements.

By combining scientific expertise with a strong commitment to quality, KROMATID provides customers with confidence in the genomic integrity data used to support critical research, development, manufacturing, and regulatory decisions.

Many different types including whole blood, PBMCs, IPS, T-cells, NK, γ δ T-cells, hepatocytes, hepatoblasts, HEK, and HEP variants.

Structural variants (SVs) are large-scale changes in chromosome structure, including deletions, duplications, inversions, translocations, and insertions. These genomic alterations can occur naturally or arise during cell engineering, gene editing, viral vector integration, or cell manufacturing.

Understanding structural variants is critical because they can affect gene function, genomic stability, cell performance, and, in some cases, patient safety. Detecting these events early in development helps researchers evaluate genomic integrity, optimize manufacturing processes, assess potential risks, and support regulatory submissions.

KROMATID's KROMASURE™ platform enables direct, single-cell visualization of structural variants at the chromosome level, allowing researchers to identify rare or complex events that may be difficult to detect using population-based genomic methods alone.

KROMATID's technology is designed for organizations developing and manufacturing advanced cell and gene therapies that require a deeper understanding of genomic integrity. Our services support biotechnology and pharmaceutical companies, academic and translational research institutions, contract development and manufacturing organizations (CDMOs), and clinical research organizations (CROs).

The KROMASURE™ platform is valuable across the development lifecycle—from early research and process development through IND-enabling studies, manufacturing, and post-market applications. It is particularly beneficial for teams working with gene editing technologies, viral and non-viral delivery systems, stem cells, immune cell therapies, induced pluripotent stem cells (iPSCs), and other genetically modified cell products where chromosome-level genomic integrity is a critical quality attribute.

KROMATID provides a unique view of genomic integrity by directly visualizing chromosomes at the single-cell level. While many genomic technologies generate population-averaged data or infer structural changes through sequencing, KROMATID's proprietary KROMASURE™ platform enables researchers to observe chromosome-scale structural variants within individual cells.

This approach can reveal rare, complex, or heterogeneous genomic events that may be difficult to detect with traditional methods alone. By providing chromosome-level insight, KROMASURE™ complements sequencing and other genomic assays, helping developers gain a more complete understanding of genomic integrity throughout cell and gene therapy development.

Combined with our scientific expertise, flexible study design, and support for RUO, GLP, and GMP testing, KROMATID delivers actionable data that helps customers make informed development, manufacturing, and regulatory decisions with greater confidence.

Directional Genomic Hybridization (dGH®) is KROMATID's proprietary chromosome imaging technology that enables the direct visualization of structural genomic changes at the single-cell level. Unlike methods that infer genomic alterations from sequencing or population-averaged data, dGH® allows researchers to examine individual chromosomes and identify structural variants such as inversions, translocations, insertions, deletions, and other chromosome rearrangements.

This unique approach provides high-resolution, chromosome-level insight into genomic integrity, making it especially valuable for evaluating gene editing outcomes, vector integration, cell manufacturing processes, and other applications where rare or complex structural variants may be important.

dGH® serves as the foundation of some of KROMATID's KROMASURE™ platform, enabling researchers and developers to generate actionable genomic integrity data that complements sequencing and other orthogonal analytical methods.

PinPoint FISH is KROMATID's proprietary fluorescence in situ hybridization (FISH) technology designed to precisely detect and localize specific DNA sequences within individual cells. Using custom fluorescent probes that bind to targeted genomic regions, PinPoint FISH enables researchers to directly visualize the location, copy number, and chromosomal context of genes, transgenes, or vector integration sites.

Unlike chromosome-based analyses that require metaphase cells, PinPoint FISH can be performed on interphase cells, allowing the analysis of a much larger number of cells and enabling the detection of rare events with greater statistical confidence. This makes it particularly valuable for assessing heterogeneous cell populations and applications where high-throughput analysis is important.

PinPoint FISH is commonly used to confirm genome editing outcomes, characterize vector integration, assess insertional copy number, and evaluate genomic integrity during cell and gene therapy development. It can be used as a standalone assay or in combination with KROMATID's KROMASURE™ platform to provide a more comprehensive understanding of genomic integrity.

Screen is based on hybridization of fluorescent probes designed against the specific sequence of the human genome while G-banding is a staining technique based on Giemsa staining of heterochromatin (dark) and euchromatin (light). The lower limit of event resolution for Screen is ~20 kb while the lower limit of event resolution for G-banding is ~ 5Mb.

No. KROMATID does not work with clinical sample types such as FFPE tissue, peripheral blood, or primary uncultured clinical specimens.

Our assays are designed for research and development applications using well-characterized cell populations, including cultured cells and cell line–based systems used in cell and gene therapy development. This ensures optimal performance of our single-cell, chromosome-level imaging technologies and the reproducibility required for high-resolution genomic integrity analysis.

If you are unsure whether a specific sample type is compatible, our team can help assess suitability during the study design process.

We do not provide services for plant cells. We can design and run custom projects for different animal species. We have carried out projects for customers using various species including canine, murine, bovine, CHO, and NHP cells.  

•  K-banding is a fit-for-purpose assay with analysis and data presentation designed to look at many cells from heterogeneous cell populations and highlight low-prevalence events in a format that provides a comparison of a treated sample to a matched donor. G-banding classically utilized in a clinical format to look at a few cells in a patient sample for an event or events that should be present at a high prevalence.

No. KROMATID does not offer its probes or assays for standalone purchase or self-directed use.

Our technologies require specialized expertise not only in assay execution, but also in the interpretation of complex, high-resolution chromosome-level imaging data. Meaningful analysis depends on deep experience in identifying and classifying structural variants, as well as understanding the biological and manufacturing context in which they occur.

For this reason, KROMATID provides its solutions as a fully supported service, where our scientific team performs the assay, conducts rigorous analysis, and delivers interpreted results. This ensures consistency, accuracy, and actionable insights that have not been reliably achieved when attempting in-house implementation.

Starting material analysis is critical because the genomic quality of your input cells directly influences the safety, consistency, and performance of the final cell or gene therapy product.

Even in carefully controlled systems, starting cell populations can contain rare structural variants, pre-existing genomic instability, or donor-to-donor variability that may not be detected using bulk or population-averaged methods. These hidden differences can be amplified during manufacturing and expansion, potentially impacting product quality and downstream clinical outcomes.

By evaluating starting material at the single-cell, chromosome level, KROMATID helps identify these rare or heterogeneous genomic events early in development. This enables better donor selection, improved process design, and a more informed baseline for monitoring genomic changes throughout the manufacturing workflow.

That is easy, fill out our contact us form and we will reach out to schedule your first consult. 

Yes. Interpretation is a core part of KROMATID’s service.

Our team of cytogenetics and genomic integrity experts does not simply generate data - we analyze, categorize, and interpret structural variant findings within the context of your specific cell and gene therapy program. This includes identifying and classifying complex chromosome-level events, assessing their potential relevance, and helping translate results into clear, actionable insights.

Because single-cell genomic data can be complex and highly technical, our goal is to ensure you do not need in-house cytogenetics expertise to understand or use the results effectively. We provide guided interpretation and scientific support so your team can confidently apply the findings to decision-making in research, process development, manufacturing, and regulatory discussions.

Our headquarters are located in beautiful Boulder, Colorado. 

We do, as long as we can safely get cells shipped in good condition we can do international testing. 

Always! Curious about how we could partner? Reach out on our Contact Us Form and we can discuss!