Third Wave Technologies Inc., have announced the formation of a preferred marketing relationship with Genzyme Genetics to provide testing with the Invader® UGT1A1 Molecular Assay for colorectal cancer patients in the North American market who are being considered for, or currently taking, the chemotherapy Camptosar® (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.