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Recently Approved HPV Test Finds Cancer-Causing Types 16 and 18, and Another Dozen to Boot

May 3, 2011

In April 2011, the FDA approved a new test that identifies high-risk types of HPV, or the human papillomavirus, the most common sexual infection in the US. Although most people clear the infection on their own, some go on to develop HPV-related disease, such as abnormal cell growth called dysplasia as well as various cancers. People living with HIV who have persistent HPV infection are at a higher risk for dysplasia and both cervical and anal cancers.


The FDA approved the cobas HPV Test based upon results from the ATHENA study of more than 47,000 women. One startling result from the study is that 1 in 10 women who tested positive for HPV 16 and/or 18 by using this test actually had cervical dysplasia despite normal results from routine Pap smears.

Although routine Paps have greatly reduced the rate of cervical cancers, more than 12,000 cases still occur each year in the US. This new test may help reduce that caseload even further by identifying the two high-risk types that account for 70% of HPV cancers (16 and 18) in addition to another dozen that can also lead to cancerous conditions.

The same types that can cause cervical dysplasia and cancer can also lead to cancerous conditions of the anus, which leads to more than 5,000 cases each year in the US. Like cervical cancer, HIV-positive people bear more of a burden of this anal condition as well. However, routine anal screening is not yet standard of care, though one hopes the test could be used similarly for preventing anal conditions.

This test adds to the other diagnostic tools that medical professionals can use to help their patients prevent cancerous conditions due to HPV infection and disease.

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