Genital Warts Advisor

Gen-Probe HPV assay launched in Europe

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• Author: Steven Johns
• June 5, 2008
• Category: hpv

Gen-Probe has launched its new Aptima HPV Assay in Europe. The diagnostic test, for detecting high-risk strains of the human papillomavirus (HPV), has been CE-marked and is now available for sale in 13 European countries.

The assay is an amplified nucleic acid test that detects 14 high-risk HPV types associated with cervical cancer. Specifically, it 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.

“Increased specificity – meaning fewer false positive results – is important so women are not subjected to the anxiety and expense of unnecessary medical procedures,” said Jack Cuzick, professor of epidemiology at the Cancer Research UK Centre for Epidemiology, Mathematics and Statistics in London, who is leading the 953-woman ‘Predictors’ study – a head-to-head comparison of various HPV assays.

The assay has been designed to run on Gen-Probe’s fully-automated Tigris instrument system and on the company’s semi-automated DTS instrument platform.

It is being manufactured in Cardiff by Molecular Light Technology, a subsidiary of Gen-Probe.

The assay is still in clinical studies in the US, and has not yet been approved for marketing in that country by the US Food and Drug Administration.

HPV is a group of viruses with more than 100 types, 14 of which are considered to be high-risk for the development of cervical cancer. Most women will be infected with HPV at some point in their lives, but most of these infections resolve without any clinical symptoms or consequences. A small number of HPV infections progress and result in disease, which can range from genital warts to cervical cancer.

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