KromaTiD Expands Their Gene Therapy Analytic Assay Suite with the Addition of GLP Genomic Integrity Karyotyping Services

LONGMONT, Colo., May 7, 2024 /PRNewswire/ — KromaTiD, a company focused on the research, development, and commercialization of single-cell genomics tools and services for the Cell and Gene Therapy (C>) Market, is launching GLP Genomic Integrity Karyotyping services at the 2024 American Society for Gene and Cell Therapy (ASGCT) Meeting in Baltimore, Booth 2217, May 7–11.

“This expansion of our best-in-class assays for the C> community ensures that we can effectively partner with drug product producers throughout their pipeline journey, from the earliest development stages to IND filing to clinical batch release, where operating in a GLP environment is needed,” says newly appointed KromaTiD CEO Jim Chomas. “We are committed to constantly improving and innovating our offerings to keep pace with the evolving requirements for cell and gene therapy product approvals. Whatever we can do to help get these therapeutics to the people who need them, we will do.”

KromaTiD’s Genomic Integrity (GI) Karyotyping service was developed in collaboration with KromaTiD’s many leading C> customers specifically to address the challenges of producing novel cell and gene therapy products such as CAR-T and CAR-NK.   GI Karyotyping from KromaTiD offers a comprehensive analysis of all classes of genomic structural variants with the depth of analysis required to detect the low frequency events that may occur in cell and gene therapy drug products. 

“Our approach to genomic integrity analysis for our cell and gene therapy customers is to write a measurement specification customized to the requirements of their cell product,” says KromaTiD Chief Technology Officer Christopher Tompkins. “Using this approach allows us to detect the specific structural variants, for instance edit-associated translocations, at the frequency that matters for a specific product. This is often below one percent, given the high quality of the genome edits performed by our customers.” 

KromaTiD’s Genomic Integrity analysis pipeline begins with unbiased G-band karyotyping that is based on measurements of both the donor and edited cells, providing valuable information on genomic structural variants related to both the editing and cell product expansion process in the same test.  KromaTiD then provides this data as a variance from the donor cells in its Genomic Integrity Pair-Wise Comparison Report.  For customers needing resolution beyond the ~10 mb provided by G-banding, KromaTiD offers other Genomic Integrity assays based on their proprietary directional Genomic Hybridization (dGH™) platform product, providing at least two orders of magnitude improved resolution for structural variant detection.

KromaTiD will be featuring their full suite of single cell genomic assays at this year’s ASGCT meeting, including:

  • Genomic Integrity Karyotyping:  Confirmatory mapping of low prevalence, edit-associated chromosomal structural variation, identification of sub-clonal cell populations and monitoring of cell and gene therapy batch stability.
  • dGH SCREEN™: Single cell, unbiased and ultra-high-resolution mapping of structural variants as small as 5 kb.
  • dGH DISCVR™: A highly resolved, unbiased approach for tracking genomic segmental rearrangements and complex structural variation.
  • dGH in-Site™: Direct, single-cell visualization of the structure of on- and off-target DNA edit sites and mapping of transgene insertions anywhere in the genome.

About KromaTiD, Inc.

KromaTiD supports research teams in academia, large pharmaceutical, and therapeutic companies with expert scientific support and unparalleled genomics tools and services. We are your partner for biomarker discovery, genomic integrity analysis of engineered cell products and structural genomic assessment.

For KromaTiD Information Contact:
Stephanie Elena at 818-723-7962

SOURCE KromaTiD, Inc.