PRNewswire - Tuesday, October 13, 1998

CMV is the most common viral opportunistic infection in transplant patients and AIDS patients, with approximately 60% and 95% of patients infected, respectively. CMV may cause complications in several sites in the body, including the retina, gastrointestinal tract, lungs, liver and central nervous system. An estimated $1 billion is spent annually in the United States on the prevention and treatment of CMV-related diseases. Currently available tests require considerable technical expertise, have variable levels of sensitivity and rely on subjective interpretation. Moreover, these tests can take up to a month to produce results. Digene's CMV Test, by contrast, provides objective results that are available the same day. The Digene CMV Test will help physicians better tailor antiviral therapies, recognizing when a patient develops drug resistance and projecting how quickly the infection will progress to chronic disease.

Evan Jones, Digene's President and Chief Executive Officer, commented, ``The FDA approval for our CMV test is an important milestone and another first in the industry for Digene. Our test is the only test for CMV DNA that is cleared by the FDA. It is also the first product in Digene's blood virus testing business to become commercially available in the U.S. and we are excited about its potential in the market. We expect that our CMV test will significantly improve patient management by providing accurate early detection of disease and by ensuring that costly and toxic CMV therapies are only administered when active CMV infection is confirmed.''

Digene Corporation 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 Digene HPV DNA Test, aids physicians in identifying women who are most at risk of having or developing cervical disease and cervical cancer. Digene's HPV Test is used in the U.S. as an adjunct to the Pap smear for cervical cancer screening and is being evaluated in selected European and South American countries as a primary cervical cancer screen either in conjunction with or separate from the Pap smear. Digene has developed and launched additional tests internationally for the detection of two of the most common sexually transmitted diseases, Chlamydia trachomatis and Neisseria gonorrhoeae. Tests for the detection and viral load monitoring of major blood viruses, including human immunodeficiency virus (HIV) and hepatitis B virus (HBV) have also been launched outside the U.S. The HIV test is available for research use only. Digene's proprietary DNA and RNA detection systems are based on its Hybrid Capture technology. The Company believes that Hybrid Capture represents a significant improvement over existing technologies because of its sensitivity, speed, ease-of-use, accuracy and ability to measure viral load.

This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may vary materially from expectations. Meaningful factors which could cause actual results to differ from expectations include, but are not limited to, uncertainty of future profitability, uncertainty of clinical trial results, uncertainty of market acceptance, risks inherent in international transactions, limited sales and marketing experience, dependence on third party reimbursement, competition, dependence on European distributor, extent of government regulations, delay in or failure to obtain regulatory approvals, uncertainty regarding patents and proprietary rights, and inability to obtain requisite additional financing, as well as other factors discussed in the Company's Securities and Exchange Commission filings.

SOURCE: Digene Corporation
981013
PR981007

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