Third Wave Technologies Inc. (NASDAQ: TWTI) today announced that the company has submitted the pre-market approval (PMA) applications for its two human papillomavirus, or HPV, testing products to the U.S. Food and Drug Administration.

“The submission of Third Wave’s two HPV PMA applications marks the completion of a monumental undertaking by the entire Third Wave team,” said Kevin T. Conroy, president and chief executive of Third Wave. “We are very pleased with the strength of the clinical trial data that is the basis for our applications.

“With the FDA product submissions behind us, we have turned the same discipline that drove the clinical trial’s execution to the continued development of our high-volume, sample-in and result-out instrument,” Mr. Conroy said. “Both our differentiated, two-product strategy and our development of a single-instrument testing solution will meet the well-known needs of HPV clinical laboratories.”

The company expects to be in market with the instrument in 2009.

Third Wave’s HPV product submissions are based on data collected during the recently completed clinical trial for its 14-type high-risk HPV and 16/18 genotyping tests. The company achieved all primary clinical endpoints in the trial. The trial, initiated in early 2006, screened more than 50,000 subjects and enrolled over 3,400 subjects, including more than 1,300 women with atypical or ASCUS Pap test results.

The company’s submission for its 14-type high-risk HPV test proposes two intended use claims. The first proposed intended use is in combination with a Pap test to assess women 30 and over for the presence of high-risk HPV types and to guide their treatment. The second proposes that Third Wave’s high-risk HPV test be used to test patients with abnormal Pap results to determine whether they should be referred to colposcopy. The company’s HPV genotyping test detects the presence of HPV types 16 and 18, the types that cause approximately 70% of cervical disease.

About the HPV Testing Market

The global market for HPV testing is projected to be approximately $250 million in 2008. The total available market is roughly $1 billion. There are more than 10 million HPV tests being performed in the United States annually with only 28% market penetration. The U.S. market is approximately $200 million annually and has grown in excess of 40% for each of the past five years.