Third Wave Technologies Inc. (TWTI), headquartered in Madison, Wisconsin, develops and markets molecular diagnostic reagents for a variety of DNA and RNA analysis applications. The company offers a number of products based on its Invader® chemistry for clinical testing. Third Wave offers in vitro diagnostic kits as well as analyte specific, general purpose, and research use only reagents for nucleic acid analysis.
The company announced that all primary clinical endpoints in the clinical trial for its human papillomavirus (HPV) tests have been achieved. HPV is a sexually-transmitted infection that affects skin and mucous members, and in some instances can cause cervical cancer. The company expects to submit the trial results to the U.S. Food and Drug Administration for both its high-risk and 16/18 genotyping products in April. The proprietary high-risk HPV test is intended to be used in combination with a Pap test to assess women 30 and over for the presence of high-risk HPV types and to guide treatment. It is also intended to test patients with abnormal Pap results to determine whether they should be referred to colposcopy.
Third Wave initiated its HPV clinical trial in early 2006. The company screened over 50,000 subjects and enrolled over 3,400 subjects from 47 sites, including more than 1,300 women with atypical squamous cells of undetermined significance (ASCUS); or in layman’s terms abnormal Pap test results. In April, Third Wave is expected to make submissions based on these data for the FDA for both its high-risk and 16/18 genotyping products, and to share the clinical trial data shortly after making the FDA submission.
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