DIGE Digene Corp (MM)

GAITHERSBURG, Md., Dec. 6 /PRNewswire-FirstCall/ -- For the first time in France and the second time in Europe, reimbursement for HPV testing for all uses -- including routine, primary screening to identify women at risk of cervical cancer -- will be offered by a major insurer, announced Digene Corp. (NASDAQ:DIGE). Effective Jan. 1, 2007, MAAF Sante will pay for HPV DNA testing of all women between the ages of 30 and 65, who are most at risk of developing cervical cancer. The insurer also will fund HPV DNA testing for women of all ages whose Pap results are inconclusive or as a "test of cure" for women treated for cervical disease. The Digene(R) HPV Test, which uses the company's proprietary Hybrid Capture(R) II (hc2) technology, is the only test for detecting the presence of high-risk types of the human papillomavirus (HPV), the cause of cervical cancer, that is clinically validated and both FDA-approved and CE-marked. "Only the combination of a negative (normal) Pap and a negative HPV test can provide a full guarantee that the risk of developing cervical cancer within the next three years is equal to zero," MAAF Sante stated when announcing its new policy. The MAAF Sante announcement follows a similar decision in January 2006 by Deutsche BKK, a major public-health insurance provider in the central Wolfsburg region of Germany, in partnership with the local gynecologists' association and a regional hospital. "This announcement in France -- coming after a parallel decision by a major insurer in Germany earlier this year -- is an important milestone for cervical cancer screening and prevention programs globally, and should trigger similar shifts in the standard of care elsewhere in France, Europe and around the world," said Rob Lilley, Digene's Senior Vice President, Global Sales and Marketing. Recently, the first HPV vaccine was approved by the U.S. FDA for girls and young women age 9-26. However, screening will continue to be important, since the vaccine protects against just two types of the virus responsible for 70 percent of cervical cancers, and has only been shown to be effective in women not yet exposed to the targeted types of HPV. About Digene A leader in molecular diagnostics, Digene develops, manufactures and markets proprietary DNA and RNA tests, with a focus on women's health. The company's flagship product, the Digene(R) HPV Test, is the only FDA-approved and CE-marked test for the human papillomavirus, the cause of essentially all cervical cancers. Digene's product portfolio also includes tests for the detection of other sexually transmitted infections, including chlamydia and gonorrhea. Digene tests are marketed in more than 40 countries worldwide. Headquartered in Gaithersburg, MD, Digene is traded on NASDAQ under the symbol DIGE. For more information, visit http://www.digene.com/ and http://www.thehpvtest.com/. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward- looking statements are not guarantees of the future as there are a number of meaningful factors that could cause the company's actual results to vary materially from those indicated by such forward-looking statements. Meaningful factors, which could cause actual results to differ from expectations include, but are not limited to, the degree of acceptance of HPV testing by physicians, uncertainty of the company's future profitability, its ability to scale up manufacturing operations to meet any increased demand, the uncertainty regarding patents and proprietary rights, the success of the company's marketing efforts, competition, risks inherent in international transactions, and the inability to obtain requisite additional financing, as well as other factors discussed in the company's Securities and Exchange Commission filings. For other factors, reference is made to the discussion in the company's annual and quarterly reports filed with the Securities and Exchange Commission. DATASOURCE: Digene Corp. CONTACT: Investors: Albert Fleury of Digene Corp., +1-301-944-7000, or Evan Smith of Financial Dynamics, +1-212-850-5606; or Media: Pam Rasmussen of Digene Corp., +1-301-944-7196, or Sean Leous of Financial Dynamics, +1-212-850-5755 Web site: http://www.digene.com/ http://www.thehpvtest.com/

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