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Gen-Probe Launches in Europe CE-Marked APTIMA(R) HPV Assay for Detection of Human Papillomavirus
Date:5/28/2008

ogy, Mathematics and Statistics in London. Prof. Cuzick is leading the 953-woman "Predictors" study, a head-to-head comparison of various HPV assays. "Increased specificity -- meaning fewer false positive results -- is important so women are not subjected to the anxiety and expense of unnecessary medical procedures," he said. Data from the Predictors study were presented by Prof. Cuzick and other independent European researchers at the 24th International Papillomavirus Conference and Clinical Workshop in November of 2007.

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 semi-automated DTS(R) instrument platform, and is expected to run on the Company's future, fully automated instrument for low- to mid-volume laboratories.

The APTIMA HPV Assay is being manufactured by Gen-Probe's subsidiary, Molecular Light Technology, in Cardiff, Wales.

The APTIMA HPV Assay is in clinical studies in the United States, and is not approved for marketing by the U.S. Food and Drug Administration.

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 the disease.

The most common test used for cervical cancer screening is the Pap test. Although the Pap test has helped reduce mortality from cervical cancer in many countries, it does have limitations. One such limitation is poor sensitivity of individual Pap smears, whi
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SOURCE Gen-Probe Incorporated
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