Third Wave receives FDA clearance of pharmacogenetic test

Madison, Wis. -- Third Wave Technologies Inc. on Monday announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Invader UGT1A1 Molecular Assay for in vitro diagnostic use.

It is the first pharmacogenetic test to be approved by the FDA for use as a companion diagnostic to a specific drug therapy.

The test is cleared for use to identify patients who may be at increased risk of adverse reaction to the chemotherapy drug Camptosar (irinotecan) by detecting and identifying specific mutations in the UGT1A1 gene that have been associated with that risk, the company reported. Camptosar is used to treat colorectal cancer and was relabeled recently to include dosing recommendations based on a patient's genetic profile.

"The selection of the right dose is one of the greatest challenges in the treatment of cancer patients," said Dr. Howard L. McLeod, professor of oncology at Washington University School of Medicine and a recognized thought-leader in the field of pharmacogenetics. "The recent expansion of available therapies for colorectal cancer has made toxicity avoidance an important aspect of the clinical decision."

The FDA, in its own news release announcing the approval of the Third Wave test, said its use could provide colorectal cancer patients with significant medical benefit. Approximately 150,000 new cases of colorectal cancer are diagnosed each year in the United States.