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DNA or Pap?

Some women's health advocacy groups are pushing the US Food and Drug Administration to not approve Roche's cobas HPV test to replace the Pap test as a first-line choice for cervical cancer screening, the AP reports.

FDA is considering making the move, as its Microbiology Devices Panel of the Medical Devices Advisory Committee just last month recommended using the cobas, which tests for HPV DNA, as a first-line option for assessing cervical cancer risk in women 25 years and older.

Groups like the American Medical Women's Association and Our Bodies Ourselves say that moving away from the well-tested Pap test would be "a radical shift" that could lead to higher medical costs, over treatment, and confusion.

"It replaces a safe and effective well-established screening tool and regimen that has prevented cervical cancer successfully in the US with a new tool and regimen not proven to work in a large US population," the groups say in a letter to FDA commissioner Margaret Hamburg.

They worry that the DNA test will lead to overtreatment of younger women who carry the HPV virus, but who have little risk of developing cervical cancer. They also say the test is not very useful by itself because "so many women have HPV that will disappear without any treatment," Diane Zuckerman of the Cancer Prevention and Treatment Fund tells the AP.

"Having an HPV test without also getting a Pap smear to check for problems is going to scare a lot of women who are not developing cervical cancer," she adds.

Although Pap testing has contributed significantly to a 50 percent decrease in cervical cancer in the US over the past 30 years, an estimated 12,000 cases of the cancer are expected to be diagnosed this year. The latest guidelines from the American Cancer Society recommend a Pap and HPV test every five years or a Pap alone every three years in women over the age of 30, but it does not recommend the HPV test in women under 30 because it would increase the odds of more invasive testing that can be harmful to the cervix and could affect pregnancies.

Roche wants FDA to clear the company to market its test to women ages 25 and up, and the FDA's microbiology devices panel recommended unanimously that the cobas test is safe and effective as a first-line screening tool.

But the cost is a concern, AP reports. The HPV test costs between $80 and $100, more than twice the $40 Pap, and Roche has proposed that women who test positive for HPV be referred for colposcopy, which can cost up to $500.

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