LGC Promochem, Europe’s leading supplier of reference standards, will bring to Europe a new milestone in DNA standards for use in drug-response genotyping assays. LGC has agreed terms with Gentris Corporation for the marketing and distribution of their pioneering GentriSure range of Human Genomic Reference Controls (HGRC).
The GentriSure products, developed at the Gentris facility in Morrisville, North Carolina, offer the first of an ever-expanding menu of highly characterised controls for a variety of key genetic polymorphisms which directly impact drug response. Currently available controls contain polymorphisms for CYP2D6, CYP2C19, CYP2C9 and VKORC1 genes. Until now, finding a consistent, reliable and commercial source of reference controls for genotyping laboratories to use in their quality assurance and proficiency testing programmes has been a challenge. The GentriSure products offer a highly characterised source of human genomic DNA and the agreement with LGC Promochem will facilitate easier 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 United States 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.”
This will be the second time in the past 12 months that the two leading companies have announced partnership agreements. In August this year, LGC and Gentris Corporation 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.
About LGC Promochem’s reference materials business
The reference materials business at LGC Promochem is a Europe-wide distribution business focused on a number of key market sectors including pharmaceutical testing, food analysis, environmental analysis, forensic science, clinical science and general analyte determination. Reference materials assist analysts dealing with a broad range of analyses to improve the accuracy, traceability and repeatability of a diverse range of chemical measurements. LGC Promochem’s head office is located at LGC’s Teddington laboratory in the UK with the network of European distribution offices including UK, France, Spain, Sweden, Italy, Germany, Poland and India. LGC Promochem has distribution partnerships with many of the world’s leading reference materials producers, including ATCC, ULTRA Scientific, Cambridge Isotope Laboratories, NMIA, Cerilliant and the Institute for Reference Materials and Measurements.
About Gentris Corporation
Gentris Corporation (gentris.com) is a leading global provider of clinical pharmacogenomic diagnostic solutions. As pioneers in the field of pharmacogenomics, Gentris is setting the standard for genetic testing controls with its GentriSure™ line of human genomic reference controls. Gentris is also developing diagnostic test kits that will deliver rapid results for direct patient testing. By providing access to these innovative personalised medicine solutions, Gentris is contributing to enhance patient management, improve patients' response to therapy and, ultimately, revolutionising medicine through pharmacogenomics.
LGC, an international science service company, is a leading independent provider of analytical and diagnostic services and reference standards. LGC’s operations comprise: LGC Forensics, Life and Food Sciences, Pharmaceutical and Chemical Services and, for products and services for laboratory quality, a single division embracing LGC Promochem, LGC’s proficiency testing offering (based in Bury, UK) and our pharmaceutical impurity reference standards business. LGC’s research-led Analytical Technology and Government Chemist division houses specialist laboratories for the delivery of contracts under the DTI's Office of Science and Innovation and to serve its designated role as the UK's National Measurement Institute for chemical and biochemical analysis. LGC is headquartered in Teddington, Middlesex, UK. LGC has laboratories located in Teddington, Runcorn (Cheshire), Culham (Oxfordshire), Risley (Cheshire), Tamworth (Staffordshire), Edinburgh (Scotland), Luckenwalde (Germany) and Bangalore (India). LGC also has offices in France, Germany, Italy, Poland, Spain, Sweden and India. In 2006, AGOWA, a specialist genomics company based in Berlin, and the Institut für Blutgruppenforschung, a provider of DNA services in paternity testing and forensic genetics based in Cologne, joined the Group.