Third Wave Completes FDA Submissions For Its Two HPV Products

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 30 Apr 2008 - 1:00 PDT

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Third Wave Technologies Inc. (NASDAQ: TWTI) 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. Third Wave expects market growth to continue in excess of 25% in the near term.

The HPV testing market in the EU is just emerging, as studies are underway evaluating the use of HPV tests as a primary screen for cervical cancer in women, which would replace Pap testing.

About Third Wave Technologies

Third Wave develops and markets molecular diagnostic reagents for a variety of DNA and RNA analysis applications to meet the needs of our customers. The company offers a number of products based on its Invader® chemistry for clinical testing. Third Wave offers in vitro diagnostic kits, and analyte specific, general purpose, and research use only reagents for nucleic acid analysis. For more information about Third Wave and its products, please visit the company's website at http://www.twt.com.

All statements in this news release that are not historical are forward-looking statements within the meaning of the Securities Exchange Act of 1934 as amended. Such forward-looking statements are subject to factors that could cause actual results to differ materially for Third Wave from those projected. Those factors include risks and uncertainties relating to the company's ability to bring new products to market as anticipated, the current regulatory environment in which the company sells its products, the market acceptance of those products, dependence on partners and customers, successful performance under collaborative and commercial agreements, competition, the strength of the Third Wave intellectual property, the intellectual property of others and other risk factors identified in the documents Third Wave has filed, or will file, with the Securities and Exchange Commission. Copies of the Third Wave filings with the SEC may be obtained from the SEC Internet site at http://www.sec.gov. Third Wave expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward- looking statements contained herein to reflect any change in Third Wave's expectations with regard thereto or any change in events, conditions, or circumstances on which any such statements are based. Third Wave Technologies, Invader and the Third Wave logo are trademarks of Third Wave Technologies, Inc.

Third Wave Technologies Inc.