Statement by Third Wave Regarding FDA’s Coumadin Relabeling Announcement

Rod Hise
The Luminis Group, Ltd.
for Third Wave Technologies Inc.

MADISON, Wis., Aug. 17 /PRNewswire-FirstCall/ — The following is a statement by Kevin T. Conroy, president and chief executive of Third Wave Technologies Inc. (NASDAQ:TWTI)
, regarding yesterday’s announcement by the U.S. Food and Drug Administration that it has approved updated labeling for the widely-used blood-thinning drug, Coumadin, to include information regarding the potential affect of a patient’s genetic makeup on dosing of the drug. Manufacturers of warfarin, the generic version of Coumadin, are to add similar information to their products’ labeling. The FDA said in its announcement that genetic testing may help optimize the use of warfarin and lower the risk of bleeding complications from the drug. Warfarin is the second most common drug implicated in emergency room visits for adverse drug events, according to the FDA.

“Third Wave applauds the FDA’s continuing efforts to move pharmacogenetics into clinical practice. We are committed to continuing our leadership in pharmacogenetics, which began with the FDA’s clearance of our UGT1A1 assay in August 2005. Earlier this year, Third Wave released analyte-specific reagents that enable clinical laboratories to build molecular assays capable of detecting the specific mutations associated with warfarin sensitivity. We look forward to providing an update on Third Wave’s FDA submission plans for our warfarin products and on other pharmacogenetic products at our analyst and investor day on September 20 in New York. Third Wave has staked out a leadership position in pharmacogenetics that makes it an important driver of future growth for the company.”