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.
This test represents the power of DNA-based testing to provide individualized medical care, said Daniel Schultz, MD, Director of FDA?s Center for Devices and Radiological Health.
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.