31 Dec Third Wave completes HPV clinical trial enrollment
Madison, Wis. – Third Wave Technologies, a Madison-based developer of molecular diagnostic products, has achieved the enrollment goals for two products designed to test for the Human Papilloma Virus, a key step in its pursuit of Food and Drug Administration approval of the HPV products.
Certain high-risk types of the HPV have been identified as a cause of cervical cancer in women. The two products under development by Third Wave 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.
Third Wave anticipates making submissions to the FDA on two HPV products during the first quarter of 2008.
Kevin T. Conroy, president and chief executive of Third Wave, said achieving the enrollment goal marks the completion of a major undertaking in the process of seeking FDA approval of the two HPV products. The total enrollment target was comprised of 2,000 normal subjects and 1,400 women with atypical Pap test results.
“We believe that the size of our study will strengthen our FDA submissions and the marketing of our HPV products, once they are approved,” Conroy said in a press release.
The next steps in the clinical trial include obtaining the final colostomy and biopsy data, validating the database, and submitting the FDA applications.
The HPV products have been the subject of a legal dispute between Third Wave and Digene Corp, a molecular diagnostics company based in Gaithersburg, Md.. Digene filed a patent lawsuit against Third Wave, claiming its Invader chemistry product violates its United States patent pertaining to HVP type 52.
In response, Third Wave has filed an anti-trust countersuit, arguing that its patent claims are narrow in scope and that Digene brought the suit to impede competition in the HPV testing market.
In July of 2007, Digene was acquired by Qiagen, a life-sciences company based in Venlo, The Netherlands.
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