The US Food and Drug Administration (FDA) has cleared the use of a new blood test that can help physicians make personalized medication treatment decisions for some patients, according to an Aug 22, 2005, news release from the FDA. The UGT1A1 molecular assay detects genetic variations that may affect how certain medications are metabolized and cleared by the body. Physicians can use this information to help determine the right medication dosage for individual patients and minimize harmful medication reactions.
The assay detects variations in UGT1A1, the gene that produces the UDP-glucuronosyltransferase enzyme. This enzyme is active in the metabolism of certain medications, such as irinotecan, a medication used in colorectal cancer treatment. Variations in the UGT1A1 gene can influence a patient's ability to break down irinotecan, which can lead to increased blood levels of the medication and a higher risk of side effects.
The assay was studied in 66 patients who were receiving irinotecan therapy. The study showed that people with one type of genetic variation have a risk of experiencing irinotecan toxicity that is five times greater than for those who do not have the genetic variation.
The molecular assay is intended to help physicians make individualized patient treatment decisions. It is not a substitute for a physician's judgment or clinical experience.
FDA Clears Genetic Test That Advances Personalized Medicine: Test Helps Determine Safety of Drug Therapy (news release, Rockville, Md: US Food and Drug Administration, Aug 22, 2005) http://www.fda.gov/bbs/topics /NEWS/2005/NEW01220.html (accessed 6 Sept 2005).
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