Cervical Cancer Screening for Developing Countries

(Gaithersburg, MD, USA).

More than 80% of women who die from cervical cancer worldwide are from developing countries. Under the new partnership, Digene will develop and manufacture a screening test based on the company's Hybrid Capture technology for detecting the human papillomavirus (HPV), which causes most cervical cancers. Digene will also obtain the necessary regulatory approvals and will sell the product on a long-term basis to government and nonprofit organizations as well as to the private sector.

The partnership agreement is part of PATH's START (screening technologies to advance rapid testing) project, initiated to develop low-cost, easy-to-use culturally acceptable tests for cervical cancer screening and suitable for areas with minimal resources and medical infrastructure. The project was begun in January 2003 with a U.S.$13 million grant from the Bill & Melinda Gates Foundation (USA) to PATH.

PATH will coordinate the clinical study and provide information on such issues as the needs and preferences of women and contribute to a cost-effective program. The research and development phase is estimated to require about five years. Upon implementation of the program and the achievement of specific milestones, PATH will provide Digene with up to $2.2 million.

"Women in developing countries are screened infrequently--sometimes just once in their lifetime--and it will be difficult to change that,” said Christopher J. Elias, M.D., president of PATH. "This means they should get the test that is the most likely to identify who needs intervention and that will allow rapid analysis.”

Worldwide, cervical cancer remains the third most common cancer, afflicting about 470,000 women every year. More than half of these die, mainly those women in developing regions such as South and Central America, subSaharan Africa, and Southeast Asia. In those regions, cervical cancer has become the leading cause of cancer deaths among women, largely because of limited access to screening and appropriate treatment. The World Health Organization (WHO, Geneva, Switzerland) estimates that only about 5% of these women had been screened for cervical cancer in the previous five years, compared to 40-50% of women in the developed countries.

Digene has developed technology originally approved by the U.S. Food and Drug Administration (FDA) for follow-up evaluation of women with abnormal Pap results, marketed as the hc2 High-Risk DNA Test. The FDA has since approved a new use: primary cervical cancer screening in women 30 and over in conjunction with a Pap smear. This use is marketed as the DNAwithPap test.

PATH is an international nonprofit organization formed to create sustainable, culturally relevant solutions, enabling communities worldwide to break longstanding cycles of poor health. By collaborating with diverse public- and private-sector partners, PATH seeks to provide appropriate health technologies and vital strategies that change the way people think and act. PATH says its work improves global health and well-being.

"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 technology--the developing world,” said Evan Jones, chairman and CEO of Digene. "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.”




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