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Large, Randomized Study Confirms HPV Testing Is More Sensitive Than Both Conventional and Liquid-Based Pap Test

08 Jun 2006

GAITHERSBURG, MD, USA | Jun 07, 2006 | A study of more than 33,000 women published in the June issue of the Journal of the

National Cancer Institute found that testing for high-risk types of the human papillomavirus (HPV) is a significantly more sensitive tool for cervical cancer screening than either conventional or liquid-based cytology (Pap testing), announced Digene Corp. (Nasdaq: DIGE). The study, which used Digene's Hybrid Capture 2 High-Risk HPV DNA Test(R) (also called The Digene(R) HPV Test), was funded in part by the European Union and the Italian Ministry of Health.

"HPV testing for high-risk types [of the virus] was more sensitive than both conventional (by approximately 40 percent) and liquid-based (by approximately 30 percent) cytology," concluded the study authors, led by Guglielmo Ronco of the Unit for Cancer Epidemiology, Centro per la Prevenzione Oncologica in Turin, Italy. The analysis of preliminary results from the New Technologies for Cervical Cancer Screening (NTCC) Study, which was conducted at nine organized cervical cancer screening programs throughout Italy, included more than 33,000 women age 35 and older.

Upon reviewing the study results, Mark S. DeFrancesco, MD, Chief Medical Officer of Women's Health Connecticut, commented, "These findings are important for physicians and payers when deciding how to integrate the coming new HPV vaccine into actual practice. Clearly, HPV testing remains an important component of cervical cancer screening. Since the vaccine will not provide complete or immediate protection, or perhaps even be appropriate for every woman, screening will continue to be critical for the foreseeable future. The combination of an HPV vaccine program long-term, and continued screening with Pap and HPV testing appears to be the most practical and effective approach to cervical cancer prevention."

Digene markets the only FDA-approved and CE-marked test for high-risk HPV, a virus that causes virtually all cases of cervical cancer. In the United States, The Digene HPV Test is approved for use along with the Pap to screen women age 30 and older, the group most at risk for developing cervical cancer.

"This is a milestone study in that it is the first randomized, controlled study to compare HPV DNA testing to both conventional and liquid-based cytology," said Attila T. Lorincz, PhD, Digene's Chief Scientific Officer and Senior Vice President of Research and Development. "It strongly reinforces results from earlier, smaller screening studies showing that the use of HPV testing as part of cervical cancer screening significantly increases our confidence that no woman at risk of malignancy will go undetected."

Worldwide, cervical cancer affects more than 400,000 women annually and, after breast cancer, is the second most common malignancy found in women. In the United States, there are an estimated 9,710 cases of cervical cancer resulting in approximately 3,700 deaths each year.

About Digene

Digene Corporation (Nasdaq: DIGE), 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 U.S. Food and Drug Administration (FDA), 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 www.thehpvtest.com. Digene's HPV test is also CE-marked in Europe both routine, primary screening and follow-up evaluation of women with inconclusive Paps. It is marketed in more than 40 countries worldwide. In addition, Digene's product portfolio 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, www.digene.com. Investors also may contact Charles Fleischman at (301) 944-7000; journalists may contact Pam Rasmussen, (301) 944-7196.

This press release may contain 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 that could cause actual results to differ from expectations include, but are not limited to, the degree of acceptance of HPV testing by physicians and the extent of reimbursement for the HPV test by third-party payers, 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.

SOURCE: Digene Corporation

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