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MADISON, Wis. and MINNEAPOLIS, Jan. 4 /PRNewswire/ -- Third Wave Technologies, Inc. and the University of Minnesota, working through Fairview University Medical Center, announced today that they have entered into a collaboration using Third Wave's proprietary Invader operating system to genotype at least 100,000 patient samples to validate the association between mutations in the gene believed to be responsible for the development of hemochromatosis, one of the most commonly inherited genetic disorders. This is the largest genotyping study ever sponsored by the National Institutes of Health (NIH). The University of Minnesota with John H. Eckfeldt, M.D., Ph.D. as Principal Investigator is the Central Laboratory for this study.
``This is a very high profile study that will have a significant impact on the credibility and feasibility of gene-based screening tests because of its scope and size,'' commented Ronald C. McGlennen, MD, Medical Director of Genetics Laboratories at Fairview University Medical Center and co-investigator of the study. ``After considerable evaluation we chose Third Wave's Invader technology for this large-scale study because it is cost-effective, simple to use and reliable. Invader assays are also readily adaptable to existing high-throughput automation and offer straightforward data interpretation.''
Research has demonstrated that mutations in the HFE gene may contribute significantly to an individual's likelihood of developing hereditary hemochromatosis, a genetic disease of abnormal iron metabolism that results in excess iron deposits throughout the body. Untreated, excess iron accumulates in the liver causing liver enlargement and damage to other organs. This can lead to development of diabetes, cardiac problems, arthritis and even death.
The purpose of the NIH-sponsored study is to validate the association between the common mutations in the HFE gene and the development of hemochromatosis, and to identify other genes that may be involved in the development of the disorder. The study will analyze a broad cross-section of Americans of varying geographic, ethnic and cultural backgrounds to determine risk profiles for hemochromatosis incidence. All samples will be tested at Fairview University Medical Center and analyzed using Third Wave's proprietary Invader assays. Patient samples will be collected at five different sites across the country, and the study will be conducted over a five-year period.
``We are extremely excited about this study because genetic screening will facilitate the diagnosis of patients at a stage where HFE-associated hereditary hemochromatosis cannot only be treated, but actually prevented,'' commented Sandra Thomas, President and Founder of the American Hemochromatosis Society. ``A study of this range and magnitude will also clarify more accurately high-risk groups for hemochromatosis.''
It is estimated that over 35 million Americans unknowingly carry one or both of the HFE mutations that are the major risk factors for hereditary hemochromatosis. Determining a person's gene status before iron overload characteristic of hemochromatosis occurs and monitoring of blood levels to implement early treatment of the disease, may prevent symptoms from developing and the resulting organ damage from occurring.
``We are very excited to be chosen to participate in such a groundbreaking study,'' stated Lance Fors, Ph.D., President and CEO of Third Wave. ``Third Wave is always looking for opportunities to be involved in these types of studies focused on better understanding the genetic basis of disease and bringing us closer to wide implementation of personalized medicine strategies.''
Third Wave Technologies, Inc. develops and provides DNA and RNA analysis technologies for use in genome research, pharmacogenomics and clinical applications.
Third Wave has filed a registration statement with the Securities and Exchange Commission for the sale of shares of its common stock. This press release shall not constitute an offer to sell or the solicitation of an offer to buy such securities nor shall there be any sale of such securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any state or jurisdiction. Any such offer may be made only by means of a prospectus. At such time when a prospectus is available, it can be obtained from Third Wave's underwriters.
SOURCE: Third Wave Technologies, Inc.
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