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Drug & Device News

By ALM Staff | Law Journal Newsletters |
October 05, 2005

FDA Clears Test That Helps Doctors Give Correct Drug Dosages

On Aug. 22, the FDA cleared for marketing a new blood test that will help doctors make personalized drug treatment decisions for some patients. The Invader UGT1A1 Molecular Assay detects variations in a gene that affects how certain drugs are broken down and cleared by the body. Doctors can use this information to help determine the right drug dosage for individual patients, and minimize harmful drug reactions. The Invader assay was studied in 66 patients receiving irinotecan therapy, a drug used in colorectal cancer treatment. The study showed that people with a certain type of genetic variation have a five times greater risk of experiencing irinotecan toxicity.

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