Genzyme Corporation has launched 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 recently cleared by the US Food and Drug Administration and was developed by Third Wave Technologies Inc. Third Wave has designated Genzyme as its preferred laboratory partner for marketing UGT1A1 in the United States.

The UGT1A1 molecular assay identifies patients who may be at increased risk for severe adverse reactions to camptosar by detecting variations in the UGT1A1 gene that have been associated with that risk. A prospective clinical study indicated that patients with one of these variations have a greater than nine-fold risk of experiencing increased white blood cell counts from camptosar than patients without it. Camptosar labelling 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 to 50 per cent of which are metastatic, claims a company release.

"The Invader UGT1A1 molecular assay is a significant addition to Genzyme's oncology testing menu. We have initiated an education program aimed at physicians because it is critical that they are aware that this test will help them understand their patients' risk of serious side effects. This will help doctors treat their colorectal cancer patients with the appropriate dose of Camptosar," said Mara Aspinall, president of Genzyme Genetics, a business unit of Genzyme Corporation that focuses on the research and development of high quality, complex testing services.

"We are very pleased that Genzyme will make this test widely available in the United States and we believe that it will play an important role in patients' course of treatment," said John J. Puisis, president and chief executive officer of Third Wave.

The UGT1A1 test is built on the accuracy, scalability and ease of use of Third Wave'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 per cent accurate compared to DNA sequencing, the standard for genotype determination.

Third Wave selected Genzyme as its preferred laboratory partner because of Genzyme's demonstrated commitment to developing, marketing and selling personalised tests for cancer therapies, added the release.

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.

Genzyme Genetics is a leading, nationwide provider of high-quality, complex diagnostic testing services for physicians and their patients.

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.