Cervical Cancer Screening Using HPV Serotyping

While cervical cancer is a rare disease of women within the United States, it remains a global medical problem: it is the second most common cancer of women and the leading cause of death, especially in developing countries. The major reason for this disparity is the lack of screening programs. Pap smears are an established cancer prevention strategy in the United States and in developed nations, yet they have proven to be expensive and difficult in those countries which lack an infrastructure to diagnose, let alone treat, cervical cancer. As a result, the burden of disease tends to be greatest in resource-poor countries.

What makes this harrowing is that cervical cancer is preventable. It is known that the cause of the majority of cervical cancer is infection with the human papillomavirus (HPV) and that changes to the cervix can be detected before cancer develops. Today, we have not one, but two vaccines available to help prevent HPV-associated disease, including cervical dysplasia and cervical cancer. These are approved for use in the United States and have been shown in studies to reduce the incidence of HPV-related disease, in both women and girls, ages 9 through 26. The Merck vaccine (quadrivalent against HPV 6,11,16,18) is further approved for boys and men aged 9 through 26.

In an article now 2 years old, an Indian study was published in the New England Journal of Medicine assessing the effect of a single round of HPV testing in India, compared to cytologic testing and visual assessment (1). This study involved over 130,000 women in 52 village clusters and showed that HPV-testing was associated with a 53% reduction in the detection of advanced disease over standard of care and a 49% improvement in death. Neither cytologic screening or visual inspection (considered the standard of care) was associated with these reductions.

While controversy remains in industrialized nations over the role of HPV-testing as standard of care (ie, in place of pap smears, in conjunction with pap smears, or as a reflex test after an abnormal pap smear), developing countries are in dire need of solutions and not debate. In this context, a remarkable partnership was announced recently between the government of the African nation of Rwanda, Quiagen (maker of an HPV screening test) and Merck (manufacturer of the Quadrivalent HPV vaccine). In this partnership, Quiagen will provide free HPV screening kits to women between 35 and 45, while Merck will donate their HPV vaccine to girls 12 to 15 years of age. More than 2 million doses of the HPV vaccine and 250,000 screening tests will be provided in this collaboration.

I hope more collaborations such as these are launched across the globe and applaud this effort to initiate and implement a collaborative cancer prevention program. It will be important to follow this development and to identify societal challenges to vaccination and testing, as well as to commit fully to the education of men and women on sexually transmitted disease, protection, and prevention. For Merck and Qiagen, I hope it will come with a future commitment to support the program beyond the first three years in order to create a sustainable model of cancer prevention programs.

1. R Sankaranarayanan, et al. NEJM 2009; 360:1385-94