FDA Approves Third Wave s PGx Test for Camptosar Adverse Events

NEW YORK, Aug. 24 (GenomeWeb News) - Third Wave this week received approval from the US Food and Drug Administration for a pharmacogenetic test that takes advantage of the recent re-labeling of a lucrative chemotherapy drug.

Third Wave claimed that its test is "the first pharmacogenetic test to be approved by the FDA for use as a companion diagnostic to a specific drug therapy," in a statement.

According to Third Wave, the FDA has cleared its Invader UGT1A1 molecular assay for use in identifying patients who may be at increased risk of adverse reaction to Pfizer's Camptosar, a chemotherapy drug for colorectal cancer.

The assay detects and identifies mutations in the UGT1A1 gene associated with that risk, and takes advantage of a recent re-labeling of Camptosar, which now includes dosing recommendation based on the patient's genetic profile.

Camptosar brought Pfizer first-quarter 2004 revenue of $212 million, up 132 percent compared to the same period in 2004, according to a statement from Pfizer. Sales in the United States account for about half of the drug's worldwide sales, Pfizer said.