FDA approves test that detects gene variations
The FDA has approved a new blood test that it says will help doctors make personalized drug treatment decisions for some patients.
The Invader UGT1A1 Molecular Assay, manufactured by Third Wave Technologies in Madison, WI, detects variations in a gene called UGT1A1 that produces the enzyme UDP-glucuronosyltransferase. This enzyme is active in the metabolism of certain drugs, such as irinotecan. Variations in the UGT1A1 gene can influence a patient’s ability to break down irinotecan, which can lead to increased blood levels of the drug and a higher risk of side effects.
The Invader assay was studied in 66 patients who were receiving irinotecan therapy. The study showed that persons with one type of genetic variation have a five times greater risk of experiencing irinotecan toxicity.
The Invader assay is intended to aid a physician in making individualized patient treatment decisions. It is not a substitute for a physician’s judgment and clinical experience, the FDA says. Other important factors that may affect dosing should be considered, such as the patient’s liver function (measured in part by the level of bilirubin), age, kidney function, and coadministered drugs.
The FDA has approved a new blood test that it says will help doctors make personalized drug treatment decisions for some patients.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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