Test for Reaction to Camptosar

A new molecular assay is for in vitro diagnostic use to identify patients who may be at increased risk of adverse reaction to the chemotherapy drug Camptosar (irinotecan). The test has been cleared by the U.S. Food and Drug Administration (FDA). 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 detects and identifies specific mutations in the UGT1A1 gene that have been associated with a risk of adverse reaction to Camptosar. This drug is used to treat colorectal cancer and was recently re-labeled to include dosing recommendations based on a patient's genetic profile.

The molecular test, from Third Wave Technologies (Madison, WI, USA) is built on the accuracy, scalability, and ease of use of the company's patented Invader chemistry. In a study submitted to the FDA, the Invader UGT1A1 molecular assay was 100% accurate compared to DNA sequencing, the standard for genotype determination.

"The selection of the right dose is one of the greatest challenges in the treatment of cancer patients,” stated Dr. Howard L. McLeod, professor of oncology at Washington University School of Medicine (St. Louis, MO, USA). "The recent expansion of available therapies for colorectal cancer has made toxicity avoidance an important aspect of the clinical decision.”

Third Wave Technologies is a leader in the development and marketing of molecular diagnostics for a variety of DNA and RNA analysis applications. "While the pharmacogenetic market is just beginning to emerge, we believe it will become increasingly valuable,” observed John J. Puisis, president and CEO of Third Wave. "Our goal is to ensure that value as the market develops and molecular diagnostic and drug pairings continue to be identified, as we expect they will be.”





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