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Gen-Probe launches Aptima HPV Assay in Europe

Gen-Probe : 29 May, 2008  (New Product)
Gen-Probe’s Aptima HPV Assay, which is a highly specific molecular diagnostic test to detect high-risk strains of the human papillomavirus (HPV), has been CE marked and is currently available for sale in 13 European Union countries.
'The CE marking and launch of our Aptima HPV Assay in Europe reflect Gen-Probe's commitment to the development of novel, more accurate molecular diagnostic tests to detect life-threatening infectious diseases such as cervical cancer,' said Carl Hull, Gen-Probe's president and chief operating officer. 'In addition, we are hopeful that, over time, our HPV test will become an important long-term financial growth driver on both our current and future automated instrument platforms.'

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,' said prof Cuzick. 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 being manufactured by Gen-Probe's subsidiary, Molecular Light Technology, in Cardiff, Wales.

The Aptima HPV Assay is in clinical studies in the USA, and is not approved for marketing by the US Food and Drug Administration.
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