MADISON, Wis., Oct. 27 /PRNewswire-FirstCall/ -- Third Wave Technologies Inc. today announced the formation of a preferred marketing relationship with Genzyme Genetics to provide testing with the Invader(R) UGT1A1 Molecular Assay for colorectal cancer patients in the North American market who are being considered for, or currently taking, the chemotherapy Camptosar(R) (irinotecan). The test was cleared recently by the U.S. Food and Drug Administration (FDA).
Third Wave selected Genzyme Genetics as its preferred laboratory partner because of Genzyme’s demonstrated commitment to developing personalized tests for cancer therapies. Genzyme will launch the UGT1A1 test as a significant addition to its diagnostic testing menu and will undertake a direct education program aimed at oncologists and pathologists throughout North America.
The Invader UGT1A1 Molecular Assay identifies patients who may be at increased risk for adverse reactions to Camptosar by detecting variations in the UGT1A1 gene that have been associated with that risk. A clinical study indicated that patients with one of these variations have a greater than nine- fold increased risk of experiencing toxicity from Camptosar than patients without it. Camptosar labeling was recently updated to include dosing recommendations based on a patient’s UGT1A1 status. Approximately 150,000 new cases of colorectal cancer are diagnosed each year in the United States, 40 percent of which are metastatic.
“We have confidence in this new partnership, given Genzyme’s proven track record marketing to practicing oncologists and pathologists,” said John J. Puisis, president and chief executive officer of Third Wave. “We believe the availability of this cutting-edge test will provide colorectal cancer patients with important information that could positively impact their treatment. Educating physicians today will pay large dividends, not only for patients who can benefit now from our UGT1A1 test, but also for the continued development of pharmacogenetics in clinical practice.”
“Third Wave’s new test is a perfect example of how personalized medicine can be implemented today. With the Invader Assay, physicians will now be able to better predict the proper dosage of therapy for patients, avoiding unnecessary side effects,” said Mara Aspinall, president of Genzyme Genetics, a business unit of Genzyme Corporation that focuses on the research and development of high quality, complex diagnostic testing services.
Third Wave’s UGT1A1 test is built on the accuracy, scalability and ease of use of the company’s unique, patented Invader chemistry. In a study submitted to the FDA as part of the company’s clearance application, the Invader UGT1A1 test was 100 percent accurate compared to DNA sequencing, the standard for genotype determination.(1)
Genzyme Genetics has launched several major new cancer diagnostic tests this year, all of which help to identify which patients are likely to respond to targeted cancer therapies. Most recently, Genzyme Genetics announced that it entered into a license agreement with the University of California at Los Angeles (UCLA) Jonsson Cancer Center to obtain exclusive, worldwide diagnostic rights to its discovery of gene mutations believed to be associated with resistance to Gleevec(R) (imatinib mesylate), the current first-line therapy for patients with chronic myeloid leukemia.
The terms of the preferred marketing agreement have not been disclosed. Third Wave also will make the Invader UGT1A1 Molecular Assay available to its current customers.
(1) n=285; 95% lower limit confidence=99%
About Colorectal Cancer
Colorectal cancer refers to cancer that starts in the colon or rectum. It is the third most common cancer found in men and women and the second leading cause of cancer-related deaths in the United States. The American Cancer Society estimates that there will be about 104,950 new cases of colon cancer and 40,340 new cases of rectal cancer diagnosed in 2005. There are approximately 1 million survivors of colorectal cancer in the United States today, due largely to earlier detection and improved treatment options.
About Third Wave Technologies
Third Wave Technologies is a leader in the development and marketing of molecular diagnostics for a variety of DNA and RNA analysis applications, providing physicians and researchers with superior tools to diagnose and treat disease. Third Wave’s Invader(R) chemistry provides the company’s customers with exceptional performance, scalability, and ease of use. The company offers a number of clinical products based on its Invader(R) chemistry for genetic testing related to multiple disease areas. For more information about Third Wave and its products, please visit the company’s website at http://www.twt.com .
About Genzyme Genetics
Genzyme Genetics is a leading, nationwide provider of high quality, complex diagnostic testing services for physicians and their patients. With CLIA-certified laboratories and counseling facilities located across the U.S., Genzyme Genetics offers extensive diagnostic testing services, supported by innovative technology and a commitment to quality service and trusted information. Genzyme Genetics is a business unit of Genzyme Corporation. One of the world’s leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Founded in 1981, Genzyme has grown from a small start-up to a diversified enterprise with more than 8,000 employees in locations spanning the globe and 2004 revenues of $2.2 billion.
This news release contains forward looking statements about Genzyme’s business and strategy, including statements about the Invader(R) UGT1A1 Molecular Assay and its expected benefits for colorectal cancer patients, such as the avoidance of certain side effects, and the marketing and sale of the UGT1A1 test by Genzyme Genetics. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include, among others, scientific, technical and manufacturing issues that could prevent the U.S. marketing of the Invader Assay as contemplated, the failure of the Invader Assay to produce diagnostic results as anticipated, the commercial acceptance of the Invader Assay, including the acceptance of the test at price levels that are economically viable for Genzyme Genetics, and the risks and uncertainties described in reports filed by Genzyme with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended, including without limitation the information under the heading “Factors Affecting Future Operating Results” in the Management’s Discussion and Analysis of Financial Condition and Results of Operations section of the Genzyme Quarterly Report on Form 10-Q for the quarter ended June 30, 2005. Genzyme cautions investors not to place substantial reliance on the forward- looking statements contained in this news release.
Invader(R) is a registered trademark of Third Wave Technologies, Inc. Genzyme(R) is a registered trademark of Genzyme Corporation. Camptosar(R) is a registered trademark of Pfizer. Gleevec(R) is a registered trademark of Novartis. All rights reserved.
Genzyme’s press releases and other company information are available at http://www.genzyme.com and by calling Genzyme’s investor information line at 1-800-905-4369 within the United States or 1-703-797-1866 outside the United States.
Third Wave Technologies Inc.
CONTACT: Laura Boscarino for Genzyme, +1-205-943-8312, or Rod Hise forThird Wave, +1-608-663-4010
