PATH and Digene partner to bring HPV testing for cervical cancer to developing countries

February 16, 2004 by PATH

Pam Rasmussen, Digene Corporation, 301.944.7196,

Seattle, Washington, and Gaithersburg, Maryland, February 16, 2004—PATH and Digene Corp. (Nasdaq: DIGE) today announced a partnership to develop a cervical cancer screening test customized to the unique needs of developing countries. Women in developing countries account for more than 80 percent of women that die from the disease worldwide.

The agreement is part of PATH's Screening Technologies to Advance Rapid Testing (START) project, which was initiated to develop low-cost, easy-to-use, culturally acceptable tests for cervical cancer screening, suitable for areas of the world with minimal resources and medical infrastructure. The START project was initiated in January 2003 with a $13 million grant from the Bill & Melinda Gates Foundation to PATH.

Under its collaboration with PATH, Digene will develop and manufacture a screening test based on its proprietary Hybrid Capture technology for detecting the human papillomavirus (HPV)which causes most cervical cancers. The company also will obtain necessary regulatory approvals and sell the product on a long-term basis to government and non-profit institutions as well as to the private sector. Using India and China as representative countries, PATH will coordinate the overall clinical study and provide information on and research issues such as women's and other stakeholders' needs and preferences, as well as contribute to cost-effectiveness modeling. The research and development phase of the project is estimated to require about five years, with PATH providing Digene up to $2.2 million upon implementation of the project plan and achievement of specified milestones.

Despite the fact that cervical cancer is highly preventable when pre-cancerous cell changes are detected and eradicated, the vast majority of women in developing countries currently have no access to screening and therapy that can prevent this disease or treat it early when it develops, said Christopher J. Elias, M.D., PATH President. A customized HPV test would provide an attractive alternative to the Pap smear, since it can provide quicker results that more accurately identify women most likely to have cervical cancer or pre-cancerous conditions. Women in developing countries are screened infrequently sometimes just once in their lifetimes and it will be difficult to change that. This means they should get the test that is the most likely to identify who needs intervention, and that will allow rapid analysis.

Rates of cervical cancer, and resulting deaths, have declined in the Western world, where screening has become routine for many women and treatment has benefited from technological advances. In fact, it now is considered one of the most preventable of the cancers afflicting women. However, worldwide, cervical cancer remains the third-most-common cancer, afflicting approximately 470,000 women every year. Of the women with the disease, 230,000 dielargely in developing regions such as South and Central America, sub-Saharan Africa and Southeast Asia. In those regions, cervical cancer has become the leading cause of cancer deaths among women, largely due to limited access to screening and appropriate treatment. One report from the World Health Organization estimated that only about 5 percent of women had been screened for cervical disease in the previous five years, compared to 40-50 percent in the developed world.

Evan Jones, Digene's Chairman and Chief Executive Officer, said, We are grateful to PATH for the opportunity to help make HPV DNA testing available to women living in regions with the least access to this life-saving technologythe developing world. This effort brings us one step closer to achieving Digene's core mission of eliminating cervical cancer so that no woman dies of the disease, no matter where she is located.

Digene is the developer of the proprietary technology that was originally approved by the US Food and Drug Administration for follow-up evaluation of women with abnormal Pap results, and is marketed as the hc2 High-Risk HPV DNA Test. In March 2003, the FDA approved a new use for the product: primary cervical cancer screening in women age 30 and older, in conjunction with a Pap smear. This use is marketed by Digene as the DNAwithPap Test. For more information, visit

PATH has worked for more than 25 years to bring appropriate health technologies to low-resource regions. For the past decade, PATH has championed the cause of cervical cancer prevention in developing countries, and has worked to bring this issue to the attention of the international health community. In 1999, PATH coordinated with four other agencies to develop the Alliance for Cervical Cancer Prevention (ACCP). For more information, visit

Editor's Note: Research on the extent of cervical cancer and the challenges of preventing/treating it in the developing world will be presented at the 21st International Papillomavirus Conference & Clinical Workshop, Feb. 20-26 in Mexico City. For more information, visit

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. Digene's primary focus is in women's cancers and infectious diseases, and its lead product is the only FDA-approved test for the human papillomavirus (HPV). Studies show that high-risk types of HPV are the cause of more than 99 percent of cervical cancer cases. Digene's HPV DNA test is approved for two indications: 1) Routine cervical cancer screening in women age 30 and older, in conjunction with a Pap test. Digene markets the product for this use under the brand name DNAwithPap. 2) Follow-up evaluation of women of any age when a Pap test conducted alone produces uncertain (ASC-US) results. For this indication, Digene markets the product as the hc2 High-Risk HPV DNA Test). For more information on HPV testing, visit The company's product portfolio also includes DNA tests for the detection of other sexually transmitted infections, including chlamydia and gonorrhea, and tests for blood viruses. For more information, visit

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are not guarantees of the future, as there are a number of meaningful factors that could cause Digene'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, the extent of reimbursement for the HPV test by third-party payers, the success of Digene's marketing efforts and its ability to scale up manufacturing operations to meet any increased demand, 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 Digene's annual and quarterly reports filed with the Securities and Exchange Commission.