New pharmacogenetic test licensed in US

29 September 2005

The US Food and Drugs Agency (FDA) has recently approved the Invader UGT1A1 Molecular Assay for sale within the United States to identify patients who may be at increased risk of adverse reaction to the chemotherapy drug Camptosar (irinotecan). This test detects variations in the UGT1A1 gene associated with reduced activity of the corresponding enzyme UDP-glucuronosyltransferase, and hence with reduced ability to metabolise irinotecan, a drug used in colorectal cancer treatment.

Daniel Schultz, Director of FDA