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HPV Screening Test Approved by FDA

Rachael Myers Lowe, (April 2, 2003) - The government has approved the first human papillomavirus (HPV) test for use in routine cervical cancer screening for women 30 years old and older. HPV has been determined the cause of virtually all cervical cancers. Worldwide, cervical cancer is a leading cause of cancer death among women although in the United States it's a relatively rare cancer; the American cancer society estimates 12,200 American women will be diagnosed with cervical cancer this year and 4,100 will die from the disease. There are more than 100 strains of the human papillomavirus. Many HPV strains have no health effects, some cause genital warts and 13 strains have been associated with cervical cancer. Usually the body clears itself of an HPV infection naturally. Persistent infection by one of several strains associated with a high risk of developing cervical cancer is what health professionals worry about. Last year, the medical establishment endorsed the use of HPV testing in the case of women whose pap smear comes back with a result known as ASC-US, or atypical squamous cells of undetermined significance.

November 28, 2003

The presence or absence of an HPV infection better defines the risk of developing cancer or a precancerous condition. The American Cancer Society has suggested HPV testing could have an important role to play in routine cervical cancer screening once the FDA approves a test, as it did yesterday in approving the Digene High-Risk HPV test which is designed to be given at the same time as a routine Pap test. In a briefing Tuesday, Attila Lorinz, PhD, Senior Vice President and Chief Scientific Officer of Digene said the importance of this new test is in it's negative predictive value. "If both parts of the combination test are negative, there's a very low chance of developing cervical disease. If either parts are positive, it indicates the woman is at higher risk and more frequent follow-up is advisable." Ralph Richart, MD, of Columbia University told the briefing this new test is a significant leap forward in cervical cancer screening since conventional pap smears miss "a substantial number of cancers and cancer precursors of the cervix.""This new test combination guarantees that patients that are in fact at risk wouldn't be put in the low risk category because of a false negative pap result...and for the first time, woman and their physicians can have confidence that a negative result really means that they are at extremely low risk - not- no risk -but almost no risk, extraordinarily low risk," Richart said. Lorinz believes the cost for this dual test is in the same range as more expensive "thin-prep" or Sure-pap" liquid pap smear cytology tests. The advantage of a double negative report could be a lengthening of the screening interval. The American Cancer Society has recommended a screening interval of every three years with a double negative test. The low incidence of cervical cancer in the US and elsewhere in the developed world is attributed to the widespread use of cervical cancer screening. Women are urged to begin annual Pap smear screening exams three years after becoming sexually active but no later than aged 21. SOURCE: Cancerpage coverage of telephone news conference with Digene representatives April 1, 2003. American Cancer Society Cervical Cancer Screening recommendations

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