Integrated DNA Technologies and SeQure Dx to advance CRISPR-based therapeutics

Integrated DNA Technologies (IDT), a global leader in CRISPR genome editing solutions, has signed 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 research use only (RUO) to current good manufacturing (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.

The licensing agreement also 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 Dr, Keith Joung, Scientific Founder of SeQure Dx and his team at Massachusetts 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.

In 2023, 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 reagents are foundational to delivering on the promise of therapies to patients and are key to accelerating the path to clinic for developers.

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, is an assay for off-target confirmation, and enables the robust analysis of resulting next-generation sequencing data.

CGMP refers to products manufactured under ICHQ7; IDT engineering runs and CGMP gRNA are for development and investigational use only. The performance characteristics of this product have not been established. This product is not intended to be used as final drug product. The purchaser is solely responsible for all decisions regarding the intended use of the product and any associated legal or regulatory obligations.

RUO: Not intended for use in diagnostic, investigational and/or therapeutic applications. Unless otherwise agreed to in writing, IDT does not intend these products to be used in clinical applications and does not warrant their fitness or suitability for any clinical diagnostic use. Purchaser is solely responsible for all decisions regarding the use of these products and any associated regulatory or legal obligations.

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