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FDA Approves Alternative Cervical Cancer Screening Test

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Alternative Cervical Cancer Screening Test Approved by FDA iStockphoto/Thinkstock

A cervical cancer screening test approved in April by the U.S. Food and Drug Administration is being hailed as the only first-line tool that will be able to prevent cervical cancer development by accelerating treatment and providing doctors with more precise information.

The cobas® HPV Test, developed by Roche Molecular Systems Inc. of Pleasanton, California, was initially approved in 2011 for women 30 years of age and older to be used in conjunction with, or as a follow up to, a Pap test that examines cervical cells for changes that might become cervical cancer.

However, the latest approval means the test can now be used as an alternative to the Pap test as the first and the only test in the United States for HPV that has been given approval for first-line primary cervical screening.

According to the company’s press release the test can provide information that guides doctors toward specific treatment options for women 25 years of age and older.

It detects DNA from 14 high-risk types of human papillomavirus, or HPV, including HPV types 16 and 18 — two types believed to cause 70 percent of cervical cancer cases.

The approval, the FDA noted, does not change current medical practice guidelines for cervical cancer screening, which are developed by groups outside the FDA.

Once considered a death sentence, U.S. mortality rates for cervical cancer have declined by almost 70 percent between 1955 and 1992, due to increased screening and other preventative measures.

In most cases, the FDA said, a high-risk HPV infection goes away on its own and does not cause any health problems. But about 10 percent of women infected with high-risk HPV develop a persistent infection that may put them at risk of cancer.

The latest FDA approval was based on a study conducted by Roche involving more than 40,000 women showing the cobas® HPV test as safe and effective.

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