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23 August, 2005: The United States Food and Drug Administration
(FDA) has approved a new blood test for marketing. The new blood test will help doctors make personalized drug treatment decisions for some patients. Variations in a gene that affects how certain drugs are broken down and cleared by the body are dtected in te Invader UGT1A1 Molecular Assay. Physicians can make use of this information to help fix the perfect dosage of drugte medicine for individual patients, and lessen adverse reactions to the drug.
Said Daniel Schultz, MD, Director of FDA's Center for Devices and Radiological Health: "This test represents the power of DNA-based testing to provide individualized medical care. These technologies can significantly improve patient management and reduce the risk of ineffective or even harmful drug therapy by telling doctors how to individualize drug dosing."
The Invader is the latest in a growing list of genetic blood tests used by physicians to personalize treatment decisions, including the Roche AmpliChip, which are used to individualize antidepressant, antipsychotic, beta-blocker, and some chemotherapy drug dosage, and TRUGENE HIV-1 Genotyping Kit, used to detect variations in the genome of the human immunodeficiency virus that make the virus resistant to some anti-retroviral drugs.
The new blood testing method, (The Invader assay) detects variations in a gene called UGT1A1 which makes the enzyme UDP-glucuronosyltransferase. This enzyme is active in the
metabolism of certain drugs, such as irinotecan, a drug 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 drug and a higher risk of side effects.
The new blood test Invader assay is intended to help the doctor make individualized decisions for treating the patient. The new blood test is not intended to substitute the doctor's judgment and clinical experience. Other important factors that may affect
dosing should be considered, such as the patient's liver function age, kidney function, and co-administered drugs.
BY OUR PHARMA CORRESPONDENT
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