Healthcare Industry News:  Papillomavirus 

Diagnostics Litigation

 News Release - January 14, 2008

Third Wave Responds to Court Ruling on Anti-Trust Claims in Digene Suit

MADISON, Wis.--(HSMN NewsFeed)--Third Wave Technologies Inc. (NASDAQ:TWTI) today responded to the U.S. District Court for the Western District of Wisconsin ruling last Friday granting Qiagen N.V.’s motion for dismissal of the anti-trust claims brought against Digene Corp. by Third Wave.

In January 2007, Digene, which has since been acquired by Qiagen, filed suit against Third Wave alleging that Third Wave infringes a single Digene patent related to the human Papillomavirus, or HPV. Third Wave responded by denying infringement and alleging anti-competitive business practices and anti-trust violations by Digene. Digene in October 2007 said it could not prevail in its patent infringement suit against Third Wave without a successful appeal of the court’s July 2007 Markman order favorable to Third Wave. Digene made its statement after it unsuccessfully asked the court to reconsider its Markman order in September 2007.

“Third Wave won the most important battle in our dispute with Digene last October when Digene said it couldn’t win its patent suit unless it successfully appealed the court’s Markman order that constructed the patent claims at issue in Third Wave’s favor,” said Kevin T. Conroy, president and chief executive of Third Wave. “We are very pleased to have accomplished our top priority in this matter: maintaining Third Wave’s freedom to operate in the valuable HPV testing market.”

“We respectfully disagree with the court’s ruling Friday on our anti-trust claims and are considering our options,” Mr. Conroy said. “We have completed our HPV clinical trial enrollment and CE Marking certification of our 14-type high-risk HPV screening and have appointed our first European HPV-product distributors. We look forward to finishing the clinical trial and to submitting two HPV products — the 14-type high-risk screening test and a genotyping test for types 16 and 18 — to the FDA in the first quarter of 2008. The market continues to seek a higher quality, more innovative HPV testing solution and Third Wave is focused on meeting that unmet need.”

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 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.


Source: Third Wave Technologies

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