Gen-Probe Launches CE-Marked APTIMA® HPV Assay in Europe
Gen-Probe has launched in Europe its APTIMA® HPV Assay, a highly specific molecular diagnostic test to detect high-risk strains of the human papillomavirus (HPV), which causes cervical cancer. The APTIMA HPV Assay has been CE marked and is currently available for sale in 13 European Union countries.
The APTIMA HPV Assay is an amplified nucleic acid test that detects 14 high-risk HPV types that are associated with cervical cancer. More specifically, the assay detects two messenger RNAs (mRNAs), E6 and E7, that are made in higher amounts when HPV infections progress toward cervical cancer. Gen-Probe believes that targeting these mRNAs may more accurately identify women at higher risk of having, or developing, cervical cancer than competing assays that target HPV DNA. Detecting HPV DNA identifies women who are infected, but HPV infections are common and many resolve without causing cervical cancer.
'By targeting two HPV genes that are associated with progression to cervical cancer, the APTIMA HPV assay may increase the specificity of cancer detection,' said Jack Cuzick, professor of epidemiology at the Cancer Research UK Centre for Epidemiology, 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® instrument system and on the Company's semi-automated DTS® 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 in clinical studies in the United States, and is not approved for marketing by the U.S. Food and Drug Administration.
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