Source: www.medscape.com
Author: Jacquelyn K. Beals, PhD

A new test for human papillomavirus (HPV) has been approved by the US Food and Drug Administration (FDA). The test, Cervista HPV 16/18 (Hologic Inc), is the first to rely on identification of DNA sequences specific to 2 high-risk HPVs that cause most cases of cervical cancer in the United States.

Among more than 100 types of HPVs, many are low-risk viruses that cause warts or noncancerous growths. Other HPVs are considered high risk because their infections more frequently lead to cancer. More than a dozen types of sexually transmitted high-risk HPVs typically cause flat, hard-to-see growths on the cervix, but most of these infections resolve on their own without causing cancer.

Persistent HPV infections, some lasting for many years with or without detectable symptoms, are the major cause of cervical cancer. Estimates in 2007 predicted that 11,000 US women would be diagnosed with cervical cancer and 4000 would die from the disease. Worldwide, the annual mortality from cervical cancer is close to 250,000. Approximately 70% of all cervical cancers are caused by HPV types 16 and 18, and factors such as smoking or bearing many children further increase the risk for cervical cancer in women infected with high-risk HPVs.

The newly approved test can identify DNA sequences from HPV 16 and HPV 18 in samples of cervical cells, even before definitive changes occur in cells of the cervix. The FDA also approved a second DNA test, the Cervista HPV HR test (Hologic Inc), which detects a wide range of nearly all the high-risk HPVs. The methodology is similar for both tests, based on identification of viral DNA sequences.

Daniel G. Schultz, MD, director of the FDA Center for Devices and Radiological Health, commented in the FDA news release, “Results from these two tests, when considered with a physician’s assessment of the patient’s history, other risk factors, and professional guidelines, can help physicians better determine risk and could lead to better patient management.”

The new tests are recommended for use in women aged 30 years or older, or those with questionable cytological results, to gain a better understanding of their risk for cervical cancer. Thus, an ambiguous Papanicolaou test, which identifies abnormal cells by microscopic examination of cervical cell samples, could be followed by the new tests that detect viral DNA, informing physicians about the presence of high-risk types of HPV and a woman’s risk of developing cervical cancer.