Until now, the UGT1A1 test has only been available to patients enrolled in studies at the University of Chicago. Third Wave had received FDA approval for its UGT1A1 test kit in August, but the test had not yet been made available to patients.
Through this licensing agreement, Mayo Clinic's reference laboratory, Mayo Medical Laboratories (MML), will make the test available to patients nationwide, starting this month.
The UGT1A1 test was developed and patented by Mark J. Ratain, M.D., the Leon O. Jacobson Professor of Medicine and Chairman of the Committee on Clinical Pharmacology and Pharmacogenomics at the University of Chicago, and colleagues. It gives doctors advance knowledge of an individual's risk for toxicity from irinotecan by revealing whether patients have one of two common versions of a gene that encodes for a protein involved in the metabolism of irinotecan.
"Although most patients tolerate the drug quite well, some patients are genetically predisposed to severe side effects from irinotecan treatment," said Ratain. "The UGT1A1 test enables us to know in advance which patients are at risk. Those patients could be given reduced doses of irinotecan or other chemotherapy drugs."
This kind of customized dosing based on a person's genetic makeup is known as pharmacogenomics and is at the forefront of 21st century medicine. The UGT1A1 test is part of a growing list of pharmacogenomic tests designed to help physicians personalize treatment options.
"Precise dosing is extremely important for cancer chemotherapy because many of these drugs are most effective at the highest possible dose yet they are also quite toxic," s
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Contact: John Easton
john.easton@uchospitals.edu
773-702-6241
University of Chicago Medical Center
21-Dec-2005