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News

New research shows the benefits of the HPV DNA test

QIAGEN : 21 May, 2008  (Company News)
Long-term data from a study published in the International Journal of Cancer showed that women screened only with a human papillomavirus (HPV) DNA test are half as likely to develop moderate to severe cervical disease over the next six years as those who get only conventional cytology (the Pap ‘smear’).
The research followed nearly 3,000 women age 35 years and older, and assessed their HPV status using Qiagen's digene HPV Test - the only such test that is both CE-marked in Europe and approved by the US Food and Drug Administration (FDA).

'These results confirm that HPV DNA testing identifies more women with disease than the Pap,' said professor Jack Cuzick, lead author of the May 15 article and professor of epidemiology at the Wolfson Institute of Preventive Medicine, affiliated with Queen Mary's School of Medicine and Dentistry in London. 'They add further support to the proposal to use HPV testing as the sole primary screen in women age 35 or older, when the risk of cervical cancer is highest.'

Participants were recruited into the study from April 1994 to September 1997 at 40 different general-medicine practices in the United Kingdom. A colposcopy exam and biopsy were used to confirm or rule out the presence of cervical disease after each woman had both the HPV test and a conventional Pap. The sensitivity of the digene HPV Test was 96 percent for disease detected in the first year - substantially higher than the Pap's 82.4 percent. In addition to the HPV test's greater ability to accurately identify women with pre-cancerous cervical cells or cancer, its specificity (the likelihood that women with positive results actually have disease) was similar to that of the Pap.

Study results also showed that the women's risk of developing cervical abnormalities in the future were significantly less when they were negative for HPV compared to when their Pap smear was normal (0.42 percent vs 0.83 percent after five years).

'These data are consistent with our findings in the Netherlands,' said professor Chris Meijer of the Department of Pathology in Amsterdam's VU University Medical Center. 'The five-year risk for developing cervical cancer is reduced by more than 60 percent when using HPV testing, compared to conventional Pap smears and possibly even liquid-based cytology. This permits extension of the interval between tests, which should significantly reduce the cost of the screening programme.'

Prof Meijer adds that despite the fact that the new HPV vaccines offer new possibilities for preventing cervical cancer, the current generation of women is dependent on improved screening strategies - of which HPV testing is one of the most promising new tools.

'These latest findings contribute significantly to the growing volume of studies demonstrating the greater peace of mind offered to women and their healthcare providers when our HPV test is incorporated into the standard of care for cervical cancer prevention,' said Peer Schatz, chief executive officer of Qiagen. 'Now the imperative is to make this lifesaving and cost-reducing technology available and accessible to all women of eligible age worldwide. When a cancer is 100 percent preventable - as cervical cancer is - it is morally unacceptable to withhold it.'
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