Gen-Probe expects to enroll approximately 7,000 women in the study. Actual enrollment, however, may vary based on the prevalence of cervical disease among women in the trial. The trial enrollment and testing are expected to take approximately two years.
The APTIMA HPV assay is designed to run on Gen-Probe's fully automated, high-throughput TIGRIS(R) instrument system, and on the Company's current and future medium-throughput instrument platforms.
Separately, Gen-Probe remains on track to introduce its APTIMA HPV assay as a CE-marked product in Europe in the second half of 2008.
About HPV and Cervical Cancer
HPV is a group of viruses with more than 100 types, 14 of which have been categorized as high risk for the development of cervical cancer. While most women will be infected with HPV at some point in their lives, the majority of these infections are transient and resolve without any clinical symptoms or consequences. However, a small number of HPV infections progress and result in disease ranging from genital warts to cervical cancer. Since most HPV infections do not result in cancer, there is a need for a more specific test to identify women at greater risk of developing that disease.
The most common test used for cervical cancer screening in the United States is the Pap test. Since the mid-1950s, screening with the Pap test has dramatically reduced the number of deaths from cervical cancer. Even so, the American Cancer Society estimates that there were more than 11,000 new cases of invasive cervical cancer in 2007, as well as nearly 4,000 deaths from the disease.
Despite the success of Pap testing in reducing mortality from cervical
cancer in the United S
|SOURCE Gen-Probe Incorporated|
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