German Association of Gynecology and Obstetrics Recommends HPV Testing for Cervical Cancer Screening
Venlo, The Netherlands, August 4, 2008 - New cervical cancer prevention guidelines issued by the German Association for Gynecology and Obstetrics (DGGG) recommend testing women 30 and over for HPV (human papillomavirus) - the primary cause of cervical cancer. The guidelines recommend that HPV testing be performed along with a Pap smear for women 30 and older. The digene® HPV Test, developed by QIAGEN (NASDAQ: QGEN; Frankfurt, Prime Standard: QIA), is currently the only HPV test approved by regulatory authorities in both Europe and the United States.
"Our recommendations recognize the large number of scientific studies that demonstrate greater accuracy in identifying women at risk of having or developing cervical cancer, when a Pap is combined with the HPV test, rather than relying on a Pap smear alone," says Professor Klaus Friese, lead author of the new guidelines and professor of gynecology at the Ludwig-Maximilians-University in Munich. "By using both tests for women 30 and over, when cervical cancer is most common, we hope to greatly reduce the number of women suffering and dying from this disease."
The DGGG guidelines specifically conclude that the sensitivity of the Hybrid Capture® II (HC2) technology used by the digene HPV Test is comparable to PCR, the standard technology used in molecular testing. However, say the guidelines, the specificity (association with actual disease) of HC2 is greater than that for PCR.
Every year, cervical cancer affects nearly 500,000 women worldwide and, after breast cancer, is the second-most-common malignancy in women. In Germany, 6,200 women are diagnosed with the disease and 1,800 die from it each year. It is estimated that 80 percent of women will get an HPV infection at some point in their lives. In most cases, the infection is cleared by the immune system or is suppressed without causing problems. However, in others, the infection persists, leading to abnormal cell changes and disease. Early detection allows early treatment, ideally before cancer develops.
The digene HPV Test has been validated in global studies that included more than 300,000 women. It has been approved by the U.S. Food and Drug Administration, is CE-marked in Europe and is also licensed for sale in many other countries. In Germany, the digene HPV Test is reimbursed by most private health insurances for routine screening. Many experts hope that public health insurance will cover HPV testing in the future for primary screening in conjunction with a Pap. One pilot screening program already initiated is a partnership between public health insurer Deutsche BKK, the Wolfsburg clinical centre and gynecologists in private practice in the city. In the program, Deutsche BKK covers the cost of the digene HPV Test as a screening test for participants 30 years and older, in conjunction with a Pap.
"Unlike other cancers, cervical cancer is virtually 100 percent preventable - if women and their healthcare providers have access to the HPV Test and other new advances in preventive care," says Peer Schatz, CEO of QIAGEN. "The new guidelines from the German Association of Gynecology and Obstetrics will play a valuable role in helping physicians - and through them, their patients - understand the most effective methods for making this disease a tragedy of the past. QIAGEN welcomes the new guidelines published by the DGGG in Germany, a country with a population of more than 80 million and in which the company has a strong presence."
QIAGEN N.V., a Netherlands holding company, is the leading 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. Assay technologies are used to make such isolated biomolecules visible. QIAGEN has developed and markets more than 500 consumable products as well as automated solutions for such consumables. 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 what is considered to be the broadest panel of molecular diagnostic tests available worldwide. This panel includes the only FDA-approved test for human papillomavirus (HPV), the primary cause of cervical cancer. QIAGEN employs more than 2,800 people in more than 30 locations worldwide. Further information about QIAGEN can be found at http://www.qiagen.com/.
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