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Diagnostics

 News Release - May 20, 2008

Study Finds QIAGEN's HPV Test Offers Greater Long-term Protection from Cervical Disease than the Pap

Research Supports Replacement of Pap with HPV Test as Front-line Screen

HILDEN, Germany, May 20 (HSMN NewsFeed) -- Long-term data from a study published in the International Journal of Cancer show 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 U.S. Food and Drug Administration (FDA).

"These results confirm that HPV DNA testing identifies more women with disease than the Pap," says 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% vs 0.83% after five years).

"These data are consistent with our findings in the Netherlands," says 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 program."

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.

The digene HPV Test is marketed by QIAGEN N.V. (NASDAQ: QGEN; Frankfurt, Prime Standard: QIA). QIAGEN N.V. -Search using:

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Its performance has been validated in global studies that included more than 300,000 women. It has been approved by the U.S. FDA for use along with a Pap in women 30 and older.

"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," says Peer Schatz, CEO 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."

About HPV and cervical cancer (http://ww.theHPVtest.com)

Worldwide, cervical cancer affects nearly 500,000 women annually and, after breast cancer, is the second most common malignancy found in women. Cervical cancer is caused by "high-risk" types of the human papillomavirus (HPV), which are sexually transmitted. It's estimated that 80 percent of women will get an HPV infection at some point in their lives. However, in most cases, the infection goes away or is suppressed by the body without causing problems. It is only infections that persist that can cause abnormal cells to form that may develop into cervical cancer if not detected and treated early. One report from the World Health Organization estimates that only about 5 percent of women had been screened for cervical disease in the previous five years, compared to 40-50 percent in the developed world.

About QIAGEN (http://www.qiagen.com)

QIAGEN NV, headquartered in the Netherlands, is the leading global provider of sample and assay technologies. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue, and assays make these isolated molecules visible to facilitate such vital activities as biological research and detection of disease. QIAGEN has developed and markets more than 500 products as well as instruments that make their use more efficient and accurate. The company provides its products to molecular diagnostics laboratories, academic researchers, pharmaceutical and biotechnology companies, and applied testing customers for purposes such as forensics, animal or food testing and pharmaceutical process control. QIAGEN's assay technologies include one of the broadest panels of molecular diagnostic tests available worldwide, including the only FDA-approved test for human papillomavirus (HPV), the primary cause of cervical cancer. QIAGEN employs more than 2,600 people in over 30 locations worldwide.


Source: Qiagen

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