Rectal Cancer

U.S. FDA grants clearance of pharmacogenetic test for in vitro diagnostic use

Published in Health and Medicine Week, September 19th, 2005

Third Wave Technologies Inc. (TWTI) 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 Invader UGT1A1 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. Camptosar is used to treat colorectal cancer and was relabeled recently to include dosing...

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Source: Health and Medicine Week (2005-09-19)

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