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FDA clears Invader UGT1A1 Molecular Assay, a pharmacogenetic test

FDA ( Food and Drug Administration ) has cleared Invader UGT1A1 Molecular Assay for in vitro diagnostic use.
It is the first pharmacogenetic test to be approved by the FDA for use as a companion diagnostic to a specific drug therapy.

The Invader UGT1A1 test is cleared for use to identify patients who may be at increased risk of adverse reaction to the chemotherapy drug Camptosar ( Irinotecan ) by detecting and identifying specific mutations in the UGT1A1 gene that have been associated with that risk.
Camptosar is used to treat colorectal cancer and was relabeled recently to include dosing recommendations based on a patient’s genetic profile.

UGT1A1 gene 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 selection of the right dose is one of the greatest challenges in the treatment of cancer patients,” said Howard L. McLeod, at Washington University School of Medicine and a recognized thought-leader in the field of pharmacogenetics. “ The recent expansion of available therapies for colorectal cancer has made toxicity avoidance an important aspect of the clinical decision.”

In a study submitted to the FDA as part of the clearance application, the Invader UGT1A1 Molecular Assay was 100% accurate compared to DNA sequencing, the standard for genotype determination.

Source: Third Wave Technologies, 2005