Gentris Corporation Expands GentriSure Line of Human Genomic DNA Reference Controls

Released on = November 15, 2006, 5:52 am

Press Release Author = Gentris Corporation

Industry = Pharmaceuticals

Press Release Summary = Controls for CYP2C9, VKORC1 and CYP2C19 genes eliminate
informed consent and consistency issues for labs using leftover specimens or
synthetic materials

Press Release Body = Research Triangle Park, North Carolina - November 15th 2006 -
Gentris Corporation (Gentris), a leading global provider of applied clinical
pharmacogenomic services and diagnostic product solutions, today announced the
expansion of the GentriSure line of Human Genomic DNA Reference Controls to include
relevant polymorphisms for the Cytochrome P450 2C9 (CYP2C9), Vitamin K Epoxide
Reductase Complex Subunit 1 (VKORC1) and Cytochrome P450 2C19 (CYP2C19) genes.

This announcement comes shortly after an FDA advisory committee recommended the
re-labeling of the drug Coumadin (generic warfarin) to include a black box warning
to indicate that the popular anticoagulant carries a significant risk of serious or
fatal bleeding. Patient genotypes for CYP2C9 and VKORC1 are known to explain more
than 50 percent of warfarin response. Approximately, one third of the 30 million
patients prescribed warfarin in the United States each year carry a mutation of
CYP2C9 that is closely associated with the drug's adverse affects1. Genetic tests
are available to identify patients at risk for experiencing adverse reactions to the
drug, however, until the introduction of the GentriSure line of Human Genomic DNA
Reference Controls, no consistent source of properly consented material had been
available.

"Laboratories conducting 2C9, VKORC1 and 2C19 testing have chosen to use leftover
specimens or synthetic material as reference controls, which can lead to serious
consistency, reliability and informed consent issues," commented Gentris president
and CEO Michael Murphy. "Proper controls are critical to ensuring that testing
meets the high standards set forth by CLIA and other regulatory agencies.
GentriSure Human Genomic DNA Reference Controls provide the assurance of
well-characterized material and the convenience of a continuous supply of
ready-to-use material."

GentriSure Human Genomic DNA Reference Controls are isolated from immortalized
B-lymphoblastoids derived from properly consented individual donors. They are
manufactured in a tightly-controlled environment and undergo rigorous quality
control testing including DNA integrity and functional testing. All defining
mutations are verified by bi-directional sequencing. Each vial contains 10
microliters at a concentration of 50 nanograms per microliter. They are available
for research use only and not for use in diagnostic procedures.

In April 2006 Gentris introduced Human Genomic DNA Reference Controls for the
Cytochrome P450 2D6 (CYP2D6) gene. The company presently offers 22 control
configurations for CYP2D6, CYP2C19, CYP2C9 and VKORC1 and is currently developing a
commercial diagnostic kit for CYP2C9 and VKORC1 which would enable rapid genetic
testing for warfarin dosing. The test is expected to be available in 2007.

1Lesko (FDA), Clinical Pharmacology Subcommittee (CPSC) of the Advisory Committee
for Pharmaceutical Sciences, November 2005.

# # #

About Gentris Corporation
Gentris Corporation is a leading global provider of applied clinical pharmacogenomic
services and diagnostic product solutions. As pioneers in the field of
pharmacogenomics, Gentris helps pharmaceutical companies and clinical research
organizations effectively integrate pharmacogenomics into their drug development
programs to deliver safer, more effective compounds to the market sooner. Gentris is
developing validated reference controls and diagnostic test kits that will bring the
promise of personalized medicine to physicians and patients, which will enhance
patient management, improve patients\' response to therapy and revolutionize medicine
through pharmacogenomics. For additional information, please visit
http://www.gentris.com.





Web Site = http://www.gentris.com

Contact Details = Jonathan Jordan
919-557-7890/919 Marketing
press@gentris.com

  • Printer Friendly Format
  • Back to previous page...
  • Back to home page...
  • Submit your press releases...
  •