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
|SOURCE Gen-Probe Incorporated|
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