NEW YORK – Noble Life Sciences, a preclinical contract research organization, has signed a distribution and OEM agreement with KromaTid, a developer of genomics tools and services, the firms announced on Tuesday. The agreement will create a complete analysis service to determine potential toxicity for novel cell and gene therapies prior to an investigational new drug application.
Financial terms of the deal were not disclosed.
Under the agreement Sykesville, Maryland-based Noble Life Sciences will combine its digital PCR service with Longmont, Colorado-based KromaTid's genotoxicity and genomic integrity solutions, namely its dGH in-Site, dGH Screen, and G-banding services.
"This is a strategic move for both companies to better address the needs of our customers, especially those requiring a very thorough analysis of a cell or gene therapy's impact on genomic integrity prior to [IND] application," Clare Rogers, KromaTid's chief marketing officer, said in a statement.
Customers can now combine the services in the KromaTid and Noble genotoxicity offerings.
The dGH in-Site directly visualizes and characterizes genome engineering by CRISPR, base editing, and transgene insertions using lentiviral integrations, homology directed repair, or transposons, the firms said.
The dGH Screen offering is a single-cell, high-resolution genomic mapping tool providing an unbiased assessment of structural variants and their prevalence, while the G-banding service is a non-genomic staining method for orthogonal confirmation of dGH Screen results.
Digital PCR has increasingly become a go-to technology for biopharma development, and the firms said their dPCR offering can be used for sensitive, quantitative detection of average transgene insertion rates, gene-editing event outcomes, and determination of copy number variation.