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Study Finds QIAGEN's HPV Test Offers Greater Long-term Protection From Cervical Disease Than the Pap
Date:5/21/2008

HILDEN, Germany, May 21 /PRNewswire-FirstCall/ --

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

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(R) 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
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