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news.Third Wave Technologies has announced that the clinical trial for its two human papillomavirus, or HPV, products is now underway. The company also revealed that it expects to submit applications for FDA approval of the two products next year.
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Clinical trial site initiations and the enrollment of women for the trial began in late July, after Third Wave came to an agreement with the FDA on the clinical trial design. More than 20 sites have been qualified to date.
Third Wave aims to 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.
“It is exciting to be involved in a study that will help to bring an alternative to the current HPV testing options,” said Dr Tyrone Malloy, chief executive and medical director of Soapstone Center for Clinical Research in Decatur, Georgia, and a 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 also announced recently that it will extend its women’s health product menu-and market opportunity-to chlamydia and gonorrhea in 2007.