The GentriSure products developed at the Gentris facility in Morrisville, North Carolina can offer highly characterised controls for a variety of key genetic polymorphisms which can directly impact drug response. Currently available controls contain polymorphisms for CYP2D6, CYP2C19, CYP2C9 and VKORC1 genes.
The GentriSure products can offer a highly characterised source of human genomic DNA and the agreement with LGC Promochem will facilitate access to the controls for laboratories across Europe and in India.
The controls are isolated from B-lymphoblastoids derived from fully consented, individual donors. DNA sequences are verified using bi-directional sequencing.
Importantly, there are no artificial DNA sequences introduced to the cell lines so the controls are virtually identical to genomic DNA isolated from typical patient samples.
Clearance for some of the products is expected from the U.S. Food and Drug Administration (FDA) early next year.
Commenting on the new partnership, Dr Matthias Brommer, Director, Laboratory Quality Products and Services at LGC, indicated the potential the new agreement with Gentris brings to the market: “We are excited by the synergy that this collaboration will create.The analysis of polymorphisms affecting drug metabolism, as with many other areas of genetic analysis, will play an increasingly important role in drug development and delivery.”
“LGC Promochem is ideally positioned to create a centre through which standards to support genetic analysis can be distributed to laboratories both in Europe and across the world.The GentriSure products offer the most highly characterised DNA controls of their type and are a welcome addition to the LGC Promochem portfolio,” Dr Brommer continued.
In August this year, LGC and Gentris Corporation have announced a licensing agreement that gives Gentris the right to make, use and sell diagnostic products and services which include testing for the CYP2D6*4 polymorphism in the US.
“We are building on the success of our earlier partnership with LGC to deliver clinical pharmacogenomic products to key markets throughout the world. This is a confirmation of our commitment to building the industry’s most robust and relevant portfolio of genetic testing reference controls and diagnostic kits,” commented Gentris CEO Michael Murphy.