Product category:
Calibration and Laboratory Instruments
News Release from: LGC | Subject: Human genomic reference controls
Edited by the Manufacturingtalk Editorial
Team on 22 December 2006
Human genomic reference controls
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 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)
This article was originally published on Manufacturingtalk on 10 Mar 2003 at 8.00am (UK)
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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.
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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.
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