March 3, 2007

Digene Faces Challenge Of Convincing Physicians To Administer HPV Test, Baltimore Sun Reports

About 19% of the 35 million U.S. women who meet the criteria to receive Digene's human papillomavirus test were given the test last year, the company recently said, the Baltimore Sun reports. The National Association of Nurse Practitioners in Women's Health last week released guidelines that suggest nurse practitioners administer the test as part of routine preventive care in women ages 30 and older (Bishop, Baltimore Sun, 1/21). Digene's DNA Pap test -- which combines the traditional Pap test with a DNA test for 13 strains of HPV -- received FDA approval in March 2003 as a primary screening tool for cervical cancer for women over age 30 (Kaiser Daily Women's Health Policy Report, 6/8/06). The test is 99% accurate at identifying changes in cervical cells, compared with an 80% accuracy rate for the Pap test. The American Cancer Society, the American College of Obstetricians and Gynecologists and the American Society for Colposcopy and Cervical Pathology recommend the HPV test. Digene's largest challenge has been getting physicians to change their mindset in regards to views about the test, Douglas White, who oversees Digene's commercial operations, said. According to the Sun, some physicians might be reluctant to offer the HPV test because the Pap test is recommended once every three years if an HPV test is negative, causing some patients to skip the recommended annual exam. Some physicians also question the necessity of the HPV test for every case in which it is approved, the Sun reports. The Abramson Cancer Center at the University of Pennsylvania on its Web site says that the test "isn't perfect" and that most women who test positive for HPV will not develop cervical cancer. The roughly $50 cost of administering the test and associated lab work is covered by most major insurers, according to the Sun (Baltimore Sun, 1/21).

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