DIGE Digene Corp (MM)

GAITHERSBURG, Md., Dec. 11 /PRNewswire-FirstCall/ -- For the first time, the federal Centers for Disease Control and Prevention (CDC) has recognized the potential benefit of HPV DNA testing for cervical cancer screening in a new publication for healthcare professionals titled "Human Papillomavirus: HPV Information for Clinicians," announced Digene Corp. (NASDAQ:DIGE). In the publication, the CDC states that "molecular tests can be used to detect HPV DNA. The only such test that is currently approved by the FDA is Digene's Hybrid Capture(R) II HPV Test." The Digene(R) HPV Test is approved in the United States for routine screening of all women age 30 and older, along with the Pap, as well as for follow-up evaluation of women of all ages with inconclusive Pap results. "In international cross-sectional studies that examined both cytology (Pap testing) and the HPV DNA test, the sensitivity of a single Pap test for identifying CIN 2 or 3 (cervical disease) or cancer ranged from 33 percent to 94 percent, (while) adding the HPV DNA test to conventional cytology increased the sensitivity to 87 percent to 100 percent," the document states. "Women who are HPV DNA negative and cytology negative are at very low risk of having CIN 2 or 3 or for developing it." The publication also discusses the introduction of the first HPV vaccine, which has been approved for girls and young women age 9-26 and can protect against the two types of the virus that are responsible for 70 percent of cervical cancers. "Although this vaccine offers a promising new approach to the prevention of HPV and associated conditions," says the CDC, "this vaccine will not replace other prevention strategies, such as cervical cancer screening ... Vaccine providers should notify vaccinated females that they will need regular cervical cancer screening as the vaccine will not provide protection against all types of HPV that cause cervical cancer." In addition, the brochure states that women "may not receive the full benefits of the vaccine if they receive it after they have become sexually active ... " "The CDC plays an essential role in setting standards for public-health providers throughout the United States," said Linda Alexander, PhD, Digene's Vice President of Women's Health. "It is gratifying to see the agency reinforce the value of HPV DNA testing in the frontline efforts to eliminate cervical cancer, and thus bring us one step closer to providing access to this lifesaving technology to women no matter what their socioeconomic status." The CDC booklet can be accessed at http://www.cdc.gov/std/HPV/hpv-clinicians-brochure.htm. 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/. DATASOURCE: Digene CONTACT: Investors: Albert Fleury, +1-301-944-7000, or Media: Pam Rasmussen, +1-301-944-7196, both of Digene; Investors: Evan Smith, +1-212-850-5606, or Media: Sean Leous, +1-212-850-5755, both of Financial Dynamics for Digene Web site: http://www.thehpvtest.com/ http://www.digene.com/

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