New DNA test outperforms PAP test for cervical cancer

Sankaranarayanan, R., Nene, B.M., Shastri, S.S., Jayant, K., et al. (2009). HPV screening for cervical cancer in rural India. New England Journal of Medicine, 360, 1385-1394.

An eight year study of over 130,000 women in India financed by the Bill and Melinda Gates Foundation is the first to show that a single screening with the HPV DNA test is better than all other methods at preventing advanced cervical cancer and death. In a cluster randomized trial of 52 villages, groups were randomly assigned to undergo screening by HPV testing (34,126 women), cytologic testing (32,058), or Visual Inspection of the cervix with Acetic Acid(VIA) (34,074) or to receive standard care (31,488, control group). Over an 8 year period of follow-up, cervical cancer was diagnosed in 127 subjects who had the HPV test (of whom 39 had stage II or higher), as compared with 118 subjects (of whom 82 had advanced
disease) in the control group (hazard ratio for the detection of advanced cancer in
the HPV-testing group, 0.47; 95% confidence interval [CI], 0.32 to 0.69). There were
34 deaths from cancer in the HPV-testing group, as compared with 64 in the control
group (hazard ratio, 0.52; 95% CI, 0.33 to 0.83). There was no reduction in risk for advanced cervical cancer or death in the PAP or VIA groups compared to the control group.

The test's manufacturer, Qiagen, with financing from the Gates Foundation, is able to provide the test for $5, a factor which is essential for use in developing countries where most women get no screening and cervical cancer kills more than 250,000 people a year.

The new test requires a cervical scraping, but it is mixed with reagents and read by a machine that runs on batteries without water or refrigeration. It takes less than 3 hours to generate results and does not require a trained pathologist. It can even work with vaginal swabs taken by women themselves.

According to the authors, women could be screened with the DNA test once at 30 and then once every 10 years.