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U.K. Government Study Supports the Use of HPV Testing in the




 

BELTSVILLE, Md., Oct. 1 /PRNewswire/ -- Digene Corporation (Nasdaq: DIGE) announced today that a government report in the United Kingdom, published today by the Imperial Cancer Research Fund, has backed testing for human papillomavirus (HPV), the cause of cervical cancer, as part of the National Cervical Screening Program. The study was conducted by The NHS Health Technology Assessment Program and was led by Professor Jack Cuzick of the Imperial Cancer Research Fund. The conclusions drawn from this report could greatly benefit the approximately 3.5 million women in the United States who are diagnosed with borderline or abnormal Pap smear results.

The UK National Health Service's Health Technology Assessment (HTA) Program report was commissioned by the U.K. government to assess the existing evidence with regards to testing for HPV. The Government has been waiting for the report before making a decision on how to use HPV within the National Cervical Screening Program. This report, in addition to other newly released British data, add to the weight of evidence in support of the inclusion of HPV testing within the National Cervical Screening Program.

In the study, a panel of experts found that HPV testing could identify which women are in need of immediate referral for colposcopy. Specifically, the report concluded, " The clearest role for HPV testing at the moment is in the management of women with borderline or mildly dyskaryotic smears. In particular those that test positive for high risk types could be referred immediately for colposcopy." The experts reviewed 2,100 research papers on HPV in cervical screening for their report and found the HPV test was more sensitive for detecting high-grade pre-cancerous changes in the cells of the cervix than normal cervical smears.

Professor Jack Cuzick who led the research stated, "By testing for the presence of this virus, the women in the United Kingdom with borderline or mildly abnormal smears will benefit significantly if HPV testing were to be introduced, since these women could immediately be told whether further investigation would be necessary or not, relieving anxiety and lowering costs associated with the unnecessary follow-up smear tests and examinations."

In reaction to the published report, Evan Jones, Chairman and Chief Executive Officer of Digene Corporation commented, "The HTA's endorsement of HPV testing underscores the utility of the test in screening for cervical cancer. The research is significant since the findings conclude that HPV testing should help ensure that only those women who are most likely to have abnormalities will need to have colposcopy. The report adds to the mounting scientific evidence on the important role HPV testing can play in the screening and management of cervical disease."

Every year in the United States, approximately 15,000 women are diagnosed with cervical cancer and 5,000 women die of the disease. Worldwide, cervical cancer affects 500,000 women annually, and after breast cancer, is the second most common malignancy found in women. In the United States, Digene's HPV test is FDA-approved as an adjunct to the Pap smear for cervical cancer screening. Of the approximately 50 million Pap smears performed in the United States annually, an estimated 3.5 million women are diagnosed with ASCUS (atypical squamous cells of undetermined significance) or borderline Pap smear results.

Digene Corporation (Nasdaq: DIGE) develops, manufactures and markets DNA and RNA tests for the detection, screening and monitoring of human diseases. Digene's products are designed to help improve clinical outcomes and reduce the overall cost of disease management. Digene's lead product, the Hybrid Capture II HPV Test, aids physicians in identifying women who are most at risk of having or developing cervical disease and cervical cancer. The Digene HPV Test is used in the U.S. as an adjunct to the Pap smear for cervical cancer screening and is being marketed in selected countries as a primary cervical cancer screen either in conjunction with or separate from the Pap smear. http://www.digene.com.

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. Such factors include the failure to attain reimbursement for Digene's Hybrid Capture II HPV test and lack of significant acceptance by the medical community. 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

CONTACT: Charles M. Fleischman, President of Digene Corporation, 301-470-6500; Investor Relations: Robert P. Jones, Ephie Bernstein, Dory Lombardo, or Media: Stacey Nield all of Morgen-Walke Associates, 212-850-5600, for Digene/

Web Site: /http://www.digene.com/



 


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Information in this article was accurate in October 1, 1999. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.