Genzyme chosen as preferred marketing partner for Third Wave's Invader UGT1A1 assay

By E. Janene Geiss

Philadelphia, Dec. 6 - Genzyme Corp. announced Tuesday the launch of 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.

The test was recently cleared by the U.S. 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, according to a company news release.

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 labeling was recently updated to include dosing recommendations based on a patient's UGT1A1 status, officials said.

"The UGT1A1 Molecular Invader 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," Mara Aspinall, president of business unit Genzyme Genetics, said in the release.

Third Wave selected Genzyme as its preferred laboratory partner because of Genzyme's demonstrated commitment to developing, marketing and selling personalized tests for cancer therapies, officials said.

Genzyme Genetics has launched several major new cancer tests this year, all of which help to identify patients likely to respond to targeted cancer therapies.

Genzyme is a Cambridge, Mass., biotechnology company.

Third Wave, based in Madison, Wis., develops and markets molecular diagnostics for a variety of DNA and RNA analysis applications to diagnose and treat disease.

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