Register for California organization says it will be first to use HPV test routinely
Digene Corp.February 4, 2004
2004 FEB 4 - (NewsRx.com & NewsRx.net) -- Digene Corp. (DIGE) announced that by the spring of this year, its DNAwithPap Test will be offered to all women 30 and older by Kaiser Permanente's Northern California Region, to better identify who is at risk of developing cervical cancer.
Although other healthcare plans and insurers have begun paying for the test when ordered by physicians, Kaiser will be the first to implement it as a "standard of care" for routine cervical cancer screening, along with the traditional Pap smear. The Northern California region is the largest of the Kaiser Permanente systems, with nearly 3.2 million members.
The DNAwithPap Test - the only such test approved by the U.S. Food and Drug Administration - detects the presence of high-risk types of human papillomavirus (HPV), which have been shown to cause virtually all cases of cervical cancer. The plan to be adopted by Kaiser Permanente throughout Northern California calls for women 30 and older to be offered the HPV test along with a Pap smear during their regular check-ups, with follow-up testing as needed depending on the results.
"It is not a surprise that Kaiser Permanente is the first healthcare organization to adopt HPV testing as a standard of care in routine cervical cancer screening, since it has been a leader in cervical cancer screening," said Evan Jones, Digene's chairman and CEO, noting that more than 80% of Kaiser's female patients receive regular Pap smears, compared to the national average of 69%. "The FDA approval of our DNAwithPap Test was earned in part due to research conducted by the organization. Kaiser Permanente also played a key role in the research performed to support the original use of our HPV test: follow-up evaluation for women with abnormal Pap results."
Prior to rolling out the new initiative, Kaiser Permanente first piloted its expanded cervical cancer screening program in two northern California areas: Sacramento and Napa/Solano. Since the April 2003 FDA approval of the DNAwithPap Test for primary, adjunctive cervical cancer screening in women 30 and older, about 90% of the Kaiser Permanente members who were offered the test - or 20,000 women - chose to receive it.
Cervical cancer is one of the few malignancies that can be prevented with early detection. Yet, the American Cancer Society estimates that in the United States alone, about 12,200 women are diagnosed with cervical cancer every year, and 4,100 die of the disease. While HPV is found in up to 75% of sexually active adults, it usually disappears without causing noticeable symptoms. It is when the infection persists over time that pre-cancerous cell changes can develop.
Digene's HPV test is an objective laboratory test for high-risk HPV. In contrast, with the traditional Pap smear, laboratory technicians visually examine a sample of cervical cells for signs of abnormal changes - often producing inexact, ambiguous results. Research has shown that the sensitivity of the Pap smear in identifying women with cervical cancer or its precursor conditions ranges from 51% to 85%. In contrast, a recent study in a leading medical journal found the sensitivity of the DNAwithPap Test to be 97%. This article was prepared by Biotech Week editors from staff and other reports. Copyright 2004, Biotech Week via NewsRx.com & NewsRx.net.
©Copyright 2004, Women's Health Weekly via NewsRx.com & NewsRx.net
