German Association of Gynecology and Obstetrics Recommends HPV Testing for Cervical Cancer Screening
"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."
SAFE HARBOR STATEMENT
Certain of the statements contained in this news release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN's products, markets, strategy or operating results are forward-looking, such statements are based on current expectations that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations and risks of dependency on logistics), variability of operating results, the commercial development of the applied testing markets, clinical research markets and proteomics markets, nucleic acid-based molecular diagnostics market, and genetic vaccination and gene therapy markets, competition, rapid or unexpected changes in technologies, fluctuations in demand for QIAGEN's, products (including fluctuations due to the level and timing of customers' funding, budgets, and other factors), our ability to obtain regulatory approval of our infectious disease panels, difficulties in successfully adapting QIAGEN's products to integrated solutions and producing such products, the ability of QIAGEN to identify and develop new products and to differentiate its products from competitors' products, market acceptance of QIAGEN's new products and the integration of acquired technologies and businesses. For further information, refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).
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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