Integrated DNA Technologies (IDT), a global leader in CRISPR genome editing solutions, inked a licensing agreement with SeQure Dx, a company focused on off-target analysis for preclinical and clinical gene modification customers, bolstering IDT’s complete CRISPR portfolio comprised of world-class RUO to CGMP solutions from design to analysis. The licensing agreement enables IDT to support cell and gene therapy developers through all phases of their CRISPR-based therapeutic programs by providing comprehensive off-target analysis services, powered by SeQure Dx’s GUIDE-seq technology, alongside IDT’s award-winning rhAmpSeq™ CRISPR Analysis System.

“Off-target effects continue to be a primary concern in genome editing and are still not fully understood,” said Sandy Ottensmann, VP/General Manager, Gene Writing & Editing Business Unit at IDT. “With an increasing pipeline of CRISPR-based therapeutics that are entering and progressing in trials, the delivery of safer and more efficient genome editing platforms to the clinic becomes paramount. IDT’s expanded off-target analysis capabilities demonstrate a transformational shift we are making to support cell and gene therapy developers in their transition to the clinic, in a drive to make life-changing therapies as safe as possible.”

Dr. Keith Joung, Scientific Founder of SeQure Dx, added, “SeQure's best-in-class off-target nomination and confirmation platforms will seamlessly complement IDT’s CRISPR-based portfolio of products and services. By combining SeQure’s & IDT’s innovative technologies, this will enhance precision and safety in gene editing, bringing transformative solutions to researchers and patients worldwide.”

The licensing agreement with SeQure Dx expands IDT’s comprehensive off-target analysis capabilities by providing the company access to SeQure Dx’s next generation sequencing-based gene editing off-target analysis technology, GUIDE-seq. Originally developed by Keith Joung’s group at Massachusetts General Hospital, GUIDE-seq is a widely used off-target nomination assay, making it an excellent starting point for developing and evaluating CRISPR-focused therapeutics. Broadly used by academic researchers, biotechs, large pharma and biopharma companies to help characterize potential off-target events in their genome editing results, GUIDE-seq provides genome-wide, unbiased identification of double-stranded breaks by sequencing. It has contributed in part to the successful development and release of multiple therapeutics.

IDT’s CRISPR Innovation Journey

Last year, to help address development and manufacturing challenges in a capacity-constrained market for CGMP/Q7 services, IDT opened a therapeutic oligonucleotide manufacturing facility in the U.S. to support the increased demand for high-quality cell and gene therapy components. These critical reagents are foundational to delivering on the promise of therapies to patients and are key to accelerating the path to clinic for developers.

With IDT’s proprietary rhAmpSeq CRISPR Analysis System, regulatory expertise, RUO to CGMP manufacturing capabilities, and dedicated support team, customers can expect differentiated off-target analysis services from a single provider for their CRISPR therapeutic development. Launched in 2021, IDT’s rhAmpSeq CRISPR Analysis System is an end-to-end solution for characterizing and quantifying the full array of on- and off-target genome editing events in CRISPR research products. The novel tool, endorsed by renowned scientists, continues to grow in popularity as an assay for off-target confirmation, and enables the robust analysis of resulting next generation sequencing data.