Third Wave Releases Gene Test

Madison, Wis. -- Third Wave Technologies Inc, a maker of molecular diagnostic products, recently announced the release of its Invader 2D6 analysis panel, which provides clinical trial laboratories with access to a broad range of pharmacogenetic assays available for the important 2D6 gene.

The panel is a pharmacogenetic testing solution that offers clinical trial laboratories the ability to configure custom assay panels. The panel is being used to increase the likelihood of positive clinical trial outcomes by supplying information about anticipated drug response in clinical trial samples, classifying them into four, clinically-useful drug-metabolism categories. These classifications enable clinical trial laboratories to help increase the efficiency, efficacy and safety of a trial.

The analysis panel provides access to a variety of important genetic changes in the 2D6 gene that affect individual drug response, including single nucleotide polymorphisms, single and multiple base-pair deletions and whole gene deletion and duplication. While 2D6 genotyping is complex, the performance characteristics of the Invader technology, most notably its specificity, reduce or eliminate this complexity.

The 2D6 enzyme metabolizes approximately 25 percent of all therapeutic drugs; genetic changes in this enzyme are the best characterized of all the drug-metabolizing enzymes. These changes can cause a seven- to 10-fold decrease in the body’s ability to “clear” these and other drugs. Approximately 10 percent of Caucasians lack any 2D6 activity due to genetic variation.

The market for consumable pharmacogenetic tests that detect mutations in 2D6 and other drug-metabolizing genes is expanding. Demand is being fueled by pharmaceutical companies desire to improve their drug development processes and by encouragement from the U.S. Food & Drug Administration to include pharmacogenetic data in new drug submissions. Pharmacogenetic tests are also expected to be increasingly by doctors to determine optimal drug therapy regimens for their patients.