A new human papillomavirus (HPV) test—intended to detect women at highest risk of serious cervical abnormalities—has been approved by the US Food and Drug Administration (FDA). In addition to providing pooled results for several high-risk types of HPV, the cobas® HPV test provides individual results for the two types of HPV that account for a large proportion of cervical cancer cases in the US: HPV16 and HPV18.

Human papillomaviruses consist of more than 100 different viruses. Some types of HPV cause warts on the hands or feet; others cause genital warts; and some have been linked with cancer, most notably cervical cancer. Each year in the United States, there are more than 12,000 new cases of cervical cancer and more than 4,000 deaths from the disease.

The recognition that certain types of HPV can cause cancer led to the development of an HPV test known as Hybrid Capture® 2. It is a pooled test for 13 high-risk types of HPV. For women with a positive result, the test does not identify the individual types of HPV that are present. Previous research has suggested, however, that information about individual HPV types may help clarify a woman’s risk of important cervical abnormalities. HPV types 16 and 18, for example, account for roughly 70% of all cervical cancers.

The cobas HPV test simultaneously tests for 12 high-risk types of HPV in addition to HPV16 and HPV18 individually. To evaluate the cobas HPV test, researchers conducted a study known as ATHENA (Addressing THE Need for Advanced HPV Diagnostics). The results showed that among women age 30 and older, one in 10 women who tested positive for HPV16 and/or HPV18 actually had cervical pre-cancer even though they showed normal results with the Pap test.

By providing more detailed HPV results, the cobas HPV test is likely to improve the detection and management of cervical precancers, with the ultimate goal of preventing cervical cancer.

Reference: Roche media release. FDA Approves Roche’s HPV Test for Identifying Women at Highest Risk for Cervical Cancer. April 20, 2011.

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