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F.D.A. Approves Pap test Alternative


Posted on Apr 26, 2014

Cervical cancer is one of the leading causes of death in American women today. Thus preventative screening has become extremely important. Now the FDA has approved an alternative to the traditional pap test, but many women’s groups are concerned about whether the new test is inferior to current pap tests.

The New York Times reports on the new test.

Roche developed the new test and it aims to identify the DNA of the human papilloma virus (HPV). The test does this by taking a direct sample from a woman’s cervix.

Some cervical cancer awareness groups are not advocating the new test saying that it is not detailed enough. This is a major concern because cervical cancer is extremely difficult to detect to begin with and is often not caught until the third or fourth stage; thus it is important to have detail-oriented tests.  

The new test presents a major shift in clinical practice and a permanent change in how women are tested. But the FDA finds that this will be a positive change. A FDA representative issued a statement to the press saying, “Roche Diagnostics conducted a well-designed study that provided the F.D.A. with a reasonable assurance of the safety and effectiveness when used as a primary screening tool for cervical cancer.”

The Times explains how the new process would work and how it could be useful, “Roche’s Cobas HPV test and HPV tests sold by other companies have been used until now as a follow-up test to help resolve ambiguous Pap results, or together with Pap testing as a primary screening tool. The new approval would allow the HPV test to be used alone as an initial screen for women 25 and older. Pap testing would be used only in certain cases as a follow-up test. Studies have shown that HPV testing can result in detection of more precancerous lesions than Pap testing.”

 

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