MADISON, Wis., Aug. 7 /PRNewswire-FirstCall/ -- Third Wave Technologies Inc. today announced that the clinical trial for its two human papillomavirus, or HPV, products is underway. Third Wave continues to anticipate submitting the applications for approval of those products to the U.S. Food and Drug Administration (FDA) in 2007.
Clinical trial site initiations and the enrollment of women for the trial began in late July, after Third Wave worked closely with the FDA on the clinical trial design. More than 20 sites have been qualified to date.
“We are pleased to be a clinical trial site for Third Wave’s HPV products,” said Arthur S. Waldbaum, M.D., president of Downtown Women’s Health Care in Denver, and a principal investigator for the study. “The clinical trial design we are using is well constructed and straightforward, fitting very nicely within our normal procedures for screening women for cervical cancer.”
“It is exciting to be involved in a study that will help to bring an alternative to the current HPV testing options,” said Tyrone Malloy, M.D., chief executive and medical director of Soapstone Center for Clinical Research in Decatur, Ga., another principal investigator for the study. “The ability to genotype HPV types 16 and 18 will generate interest in light of the recent FDA approval of the vaccines.”
Third Wave announced in July that it will submit applications to the FDA for the approval of two HPV products: a screening test to detect the presence of 14 high-risk types of HPV and a genotyping test to detect two specific types of HPV-16 and 18. These two HPV types cause approximately 70% of the cases of cervical cancer.
The global market for HPV testing is approximately $150 million and growing at more than 30% a year. Third Wave also announced recently that in 2007 it will extend its women’s health product menu-and market opportunity-to chlamydia and gonorrhea. The global market for chlamydia and gonorrhea testing is more than $200 million and when combined with HPV testing, represents approximately 20% of the global molecular diagnostic market.
“Third Wave’s HPV products remain the company’s top priority and we are excited to announce our next step forward in bringing FDA-approved products to this large and growing market,” said Kevin T. Conroy, president and chief executive of Third Wave. “Because Third Wave’s study design is within the current standard of care for HPV testing and cervical disease management, we are confident in our ability to complete the clinical trial on time and on budget. We believe our HPV products can create significant value for both our customers and shareholders.”
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(R) 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 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.
CONTACT: Rod Hise of Third Wave Technologies Inc., +1-608-663-4010
Web site: http://www.twt.com//
