Readying health systems for new cervical cancer screening tests

Liu wakes and rises from her bed, careful not to disturb her husband and daughter. She hurriedly goes about feeding the chickens, watering the vegetable garden, and preparing the morning meal.

Mother-in-law Wai knows Liu has a medical appointment later in the day. “Why are you going to the hospital when there is so much work to be done here at home? Do you feel sick?” Liu explains that the village elders and the barefoot doctor came to her house a month ago. They asked her to join other women from the village in a screening program for a women’s cancer—cervical cancer. They promised that if Liu had any signs of the disease the hospital would pay for her treatment, plus she would be helping to develop a new test that would be easier to use.

“I think this cancer test is a good thing. It will help women not to cause their family much debt—and keep them alive to take care of their families,” Liu noted. Then she heard the county hospital transport coming down the dirt road and hurried to join her neighbors.

Liu’s situation illustrates experiences common in China and other developing countries, where 200,000 women each year die from cervical cancer—often in the prime of their life. More than 80 percent of the new cases identified annually occur among women in developing countries. Yet it is a disease that is relatively simple to prevent.

Over the past 40 years cervical cancer rates have been dramatically reduced in the United States and other industrialized countries through widespread use of the Pap test—cancer detected early responds well to treatment. But Pap has proven difficult and expensive to roll out in the developing world due to the need for sophisticated laboratories and highly trained technical staff. Pap screening sometimes is available to small numbers of wealthy women in capital cities, but almost never to villagers like Liu.

Now, thanks in part to the Chinese women who volunteered to participate in the START-UP project, groundbreaking approaches to screening for cervical cancer promise to bring better protection to women, no matter where they live. Working with private-sector collaborators, we have helped develop sensitive molecular and biochemical tests designed specifically for use in places where resources for health care are scarce. The new tests have potential to reduce the cost, need for training, and repeated testing that puts Pap smear screening programs out of reach for millions of women. We’re working now to ensure that once the new tests hit the market, they will be appropriate for the settings in which they’ll be used.

Different places, different needs

Because those settings can vary greatly, we have worked with our partners to develop two different test formats using different technologies. Both tests are based on a cervical or vaginal swab, provided by the woman herself or obtained by a health care provider. Health workers with minimal training and equipment can process either test in a day or less. This rapid result means women who seldom have the means to travel to health care centers may be treated at the same facility where they are tested, on the same day.

One of the tests, developed in collaboration with QIAGEN Corporation (formerly Digene), is called “careHPV.” It detects DNA from human papillomavirus (HPV), the virus that causes cervical cancer. The other test, which we developed with Arbor Vita Corporation, detects a viral protein marker produced by cancerous cells. CareHPV likely will become commercially available in 2010 or 2011. The Arbor Vita test is still in development.

Introducing the new technology

While the development of new tests is a significant leap forward, making sure they are available and meet women’s needs are equally important. While research and development of the tests advanced, we worked with our partners to ensure that the new tests would be cost-effective, acceptable to women and their health care providers, and supported by the international health care community and government health agencies.

We have joined with ministries of health, cancer experts, and community leaders in India, Nicaragua, and Uganda to organize demonstration projects in which women are screened using careHPV. Their experiences will help health system managers in other countries compare various screening approaches and plan for long-term, wide-scale adoption of a screening and treatment program.

The demonstration projects will:

• Generate evidence on the feasibility, effectiveness, and acceptability of the new DNA test alongside other screening methods.
• Provide our manufacturing partner with information and motivation for moving the test into the public health sectors of developing countries.
• Share tools and lessons learned with other countries in the region to support their efforts in cervical cancer prevention.

Planning for the future

To help health services get ready to incorporate the new tests, we are also working with our partner Jhpiego to set up regional training “centers of excellence” in the developing world. At these centers, carefully selected health care providers will receive training in triage and in treatment for women whose test results are positive. They, in turn, will train others.

Our team is working closely with other regional and global groups such as the Cervical Cancer Action coalition, the Alliance for Cervical Cancer Prevention, and the World Health Organization to promote alternative screening and treatment techniques for cervical cancer (including the very simple, but less-sensitive “visual inspection with acetic acid” approach and the highly sensitive DNA and biomarker tests). Together, our goal is to make prevention of cervical cancer available to all women, no matter where they live.

Photos, from top: Cancer Institute Chinese Academy of Medical Sciences, Miguel Alvarez.