A non-sequencing technique for monitoring the off-target effects of gene editing has been launched for cell and gene therapy manufacturers. KromaTiD’s dGH-in-Site™ service was recently launched with the aim of improving the safety of personalized medicines involving genome editing.
Directional Genomic Hybridization (dGH) technology, which reportedly is unique to KromTiD, was designed to detect the mis-repairs of double-strand breaks in DNA that can happen when cells are edited with CRISPR or another method.
The new service was developed to help developers of chimeric antigen receptor T-cell (CAR-T) therapies to detect mis-repairs and transgene integration events during T-cell editing.
“Not understanding structural variants that occur during the editing process could pose a risk to patients,” says Christopher Tompkins, PhD, CEO of KromaTiD, who hopes the in-Site™ service will also help cell and gene therapy manufacturers with their process design and quality assurance.
The technology is intended to complement traditional next-generation sequencing (NGS).
“We think it’s a necessary and essential technology,” he explains. “Using sequencing, gene editors can effectively measure off-target editing. By combining NGS with dGH measurements of mis-repair, they get a more complete picture.”
According to Tompkins, dGH is orders of magnitude better at detecting chromosomal rearrangements than current technologies, such as Giemsa (G) banding. G-banding involves staining chromosomes and has a resolution of around 10 megabases, he explains, whereas dGH has a resolution of 3kb.
The dGH technology, which was developed with help from the U.S. NIH and NASA, is already being used, he says, for assessing astronauts for damage from ionizing deep space radiation and for testing batches of edited cells.
Other applications, include detecting rare genetic diseases, validating induced Pluripotent Stem Cell (iPSC)-based therapeutics, and developing CHO cell lines for bioprocessing applications, he tells GEN.
The company, which entered the gene editing market in 2017, is currently offering the in-Site service to its existing customers. They intend to roll it out to new customers before year end.