dGH™ and dPCR Assays for Genomic Integrity
KromaTiD and Noble Life Sciences create the ultimate assays for structural variation and transgene mapping.
From one sample submission analyze your therapies for mutagenic activity, DNA mis-repair, and structural variations to 1.5 kb.
Pair Noble’s digital PCR with KromaTiD’s dGH in-Site™ and SCREEN™ for a comprehensive analysis of genomic integrity. Regardless of your gene editing mechanism we can monitor all on and off target editing outcomes with our direct hybridization and biochemical assays. By providing the widest range of unbiased variant detection available, we give you the tools to accelerate your drug development pipeline. Paired with our Genomic Integrity G-Band Karyotyping services for cell and gene therapy programs you will get the most comprehensive genomic integrity analytical package for your regulatory filings.
The Power of dGH Assays
By providing single cell analysis that reliably detects low-frequency and complex variations in heterogeneous cell populations, dGH assays are ideal for tracking cellular engineering outcomes, biomarker discovery and identifying potentially disease driving variants. Our assays help you to understand genetic diversity and the causes of genetic diseases.
dGH in-Site: Through structural analysis of baseline and edited cell populations, dGH in-Site™ helps you optimize any editing process including CRISPR/CAS, TALEN and zinc-finger. Quantify and identify on and off-target effects and provide a crucial metric for quality control in gene editing trials and experiments regardless of the gene editing method.
dGH SCREEN: A high resolution karyotyping method performed in 5 colors identifies previously undetected structural variants or biomarkers in an unbiased manner. Giving you a whole genome view of stability. It produces the kinds of rearrangement data needed to create stability and structural variance profiles for complex, heterogeneous cell populations.
For any assay KromaTiD offers, our team of experts collaborates with you to build and then execute the appropriate assay development plan and qualification study protocols to match your research, regulatory filing and product testing needs.
Noble Life Sciences Digital PCR
Transgene Copy Number Analysis: dPCR allows for the detection and quantification of copy number variation of endogenous genes and trans genes inserted into the genome by any method.
Digital PCR Applications for Cell and Gene Therapy products provide unrivaled Precision and Accuracy for Quality Manufacturing. Assays include vector copy number, transgene copy number, percentage of modified cells and contaminate testing. Noble’s dPCR process is a reproducible and easy way to measure the percentage of modified and edited cells and quantify vector number with small sample requirements so it can be applied at multiple steps during the cell therapy manufacturing process.
KromaTiD’s Genotox G-Band Karyotyping for QC provides a study plan to qualify cytogenetic release assays as a release test to monitor batch-batch consistency.
Unlock the Synergy of Noble and KromaTiD
Together, we accelerate your drug development pipeline, supporting regulatory compliance and the highest standards of genomic integrity. Contact us today to embark on your genotoxicity assessments and discover the limitless potential of our joint services.