GAITHERSBURG, Md., Jan. 12 /PRNewswire-FirstCall/ -- Europe's first cervical cancer screening program using routine HPV testing will be implemented by Deutsche BKK, a major public-health insurance provider in central Germany, in partnership with the local gynecologists' association and a regional hospital, announced Digene Corporation . The protocol adopted by BKK requires use of The Digene(R) HPV Test, also marketed as the DNAwithPap(R) Test. It is the only FDA-approved test for high-risk types of the human papillomavirus (HPV), which cause virtually all cases of cervical cancer. The test is approved in the United States for use along with the Pap to screen women age 30 and older, the group most at risk of developing cervical cancer.
"This announcement in Germany is an important milestone for cervical cancer screening and prevention programs globally, and will trigger the attention of other countries in Europe with similar public healthcare systems as a new standard of care," said Xavier Bosch, MD, Chief of the Epidemiology and Cancer Registration Unit for the Catalan Institute of Oncology in Spain. "Implementation of HPV DNA testing for routine screening introduces on a large scale the next-generation technology for cervical cancer screening, which has proven to offer significant advantages for the early detection of cervical cancer and its precursor conditions around the world."
Under the new protocol of Deutsche BKK, which serves the Wolfsburg region of Germany (home of Volkswagen), all women age 30 and older will be tested for high-risk HPV along with the Pap. Women who have HPV and an abnormal Pap will be referred for an immediate colposcopy. Those who have HPV but a normal Pap will be re-tested in 9-12 months, unless they choose to go right to colposcopy due to anxiety. Women who do not have HPV but an abnormal Pap will be re- tested as well.
"The Wolfsburg integration of routine HPV testing into a disease- management approach should have a ripple effect over time throughout the rest of Germany, Europe as a whole and even in other parts of the world, such as Latin America and the Asia-Pacific, where they have similar healthcare systems," said Evan Jones, Digene's Chairman and Chief Executive Officer. "Cost-effectiveness is critical for publicly funded health programs, and it is increasingly recognized that HPV testing can significantly increase the ability to prevent the morbidity and mortality associated with cervical cancer, while focusing scarce healthcare resources on women most at risk."
About Digene
Digene Corporation , based in Gaithersburg, MD, develops, manufactures and markets proprietary DNA and RNA testing systems for the screening, monitoring and diagnosis of human diseases -- with a focus on women's cancers and infectious diseases. The company's hc2 High-Risk HPV DNA Test(R) is the only test for human papillomavirus approved by the FDA, and is approved for both follow-up evaluation in women with inconclusive Pap results and for primary adjunctive screening with the Pap test in women age 30 and older. For primary adjunctive screening, it is marketed as both The Digene HPV Test and the DNAwithPap(R) Test. These brand names do not refer to the Digene product that tests for several types of the virus commonly referred to as "low-risk HPV," which are not associated with cervical cancer. For more information, visit http://www.thehpvtest.com. Digene's product portfolio also includes DNA tests for the detection of other sexually transmitted infections, including chlamydia and gonorrhea, as well as tests for blood viruses. For more information, visit the company's Web site, http://www.digene.com.
Digene CorporationCONTACT: Charles M. Fleischman, President, +1-301-944-7000, or Media: PamRasmussen, +1-301-944-7196, both of Digene Corporation; or Sean Leous ofFinancial Dynamics, +1-212-850-5600, for Digene Corporation
Web site: http://www.digene.com/
