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FDA Approves HPV Test for Cervical Cancer

Detects presence of high-risk strains of virus believed to cause disease

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The FDA approval followed a unanimous vote by the agency's Medical Devices Advisory Committee Microbiology Panel in March that concluded the test was safe and effective as a first-line screen for cervical cancer.

Testifying before that expert panel, Dr. David Chelmow, chair of the department of obstetrics and gynecology at Virginia Commonwealth University School of Medicine, said that "cervical cancer screening has been a huge success in decreasing cervical cancer incidence and death."

Chelmow, representing the American College of Obstetricians and Gynecologists, added that "the college strongly supports further improving cervical cancer screening through the introduction of new paradigms such as HPV testing for primary screening. HPV testing as a primary screening method for cervical cancer is very promising, and appears effective for screening for cervical cancer."

Dr. Andrew Menzin, a gynecologic oncologist at North Shore University Hospital in Manhasset, N.Y., told HealthDay that "HPV testing has been a remarkable advance in cervical cancer screening."

Its greatest value is helping to decide whether a follow-up colposcopy is needed, he said. "The idea of reversing the order of testing is an approach to try to refine and minimize who [unnecessarily] goes on to colposcopy," he said.

Whether doctors will accept using an HPV test first instead of a Pap test will depend upon the clinical trial data supporting it and on doctors and patients being educated about it, Menzin said.

He noted that current guidelines still favor using the Pap test first, "but the guidelines continue to evolve."

There are two approved vaccines, Gardasil and Cervarix, that can protect against HPV. The U.S. Centers for Disease Control and Prevention recommends that all girls and boys be vaccinated between the ages of 9 and 11.

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