MADISON, Wis., Dec. 31, 2007– Third Wave Technologies Inc. (NASDAQ: TWTI) today announced that the company has achieved the subject enrollment goals for its HPV-products clinical trial.
The total enrollment target was comprised of 2,000 normal subjects and 1,400 women with atypical, or ASCUS, Pap test results. The next steps in the clinical trial include obtaining the final colposcopy and biopsy data, validating and locking down the database, opening the database, and completing and submitting the FDA PMA applications.
“Achieving this enrollment goal marks the completion of a major undertaking by Third Wave in the process of seeking FDA approval of our two HPV products,” said Kevin T. Conroy, president and chief executive of Third Wave. “We believe that the size of our study will strengthen our FDA submissions and the marketing of our HPV products, once they are approved.”
Third Wave anticipates making submissions to the FDA on two HPV products during the first quarter of 2008. The two products include a test that will screen for 14 high-risk types of HPV and a test that will enable clinicians to determine if a patient is infected with HPV type 16 or 18, the two most carcinogenic types.
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.
