NEW CERVICAL-CANCER TEST CAUSING CONCERN.

Byline: Evan Henerson Staff Writer

A low-cost test that can help women over 35 detect early signs of cervical cancer without a doctor's visit has oncologists and women's health experts concerned that women may start skipping annual visits to their gynecologist.

Regardless of its convenience and low cost (about $17-$30), doctors say a new test to detect the human papillomavirus (HPV) - a sexually transmitted virus known to cause most cases of cervical cancer - should not replace the Pap smear. Skipping an annual exam also means losing the benefit of a breast, pelvic and vaginal exam that a $75-$125 office visit includes.

``A full exam should be performed even if you have had this test,'' said Dr. Kathryn McGonigle, a gynecologic oncologist at the UCLA School of Medicine. ``I'd be very careful about saying this test should replace the Pap smear. That's a dangerous message that we don't want people taking away from this.''

The HPV test, manufactured by Maryland-based Digene Corp., would allow women to collect samples of their own vaginal cells for analysis in a laboratory. The presence of HPV doesn't automatically mean a woman has cancer. If the HPV virus is detected, researchers say the woman should see a gynecologist for further tests and possible treatment.

Results of a study of high-risk populations in South Africa published last week in the Journal of the American Medical Association concluded that the HPV test is ``less specific than but as sensitive as (Pap) smears for detecting high-grade cervical disease in women aged 35 and over, and HPV testing offers an important new way to increase screening in settings where cytology is not readily performed.''

The study's conclusions drew skepticism from City of Hope Cancer Center's Dr. Sharon Wilczynski, who found the results interesting, but ultimately ``not ready for prime time.''

``It shouldn't change the way women are taking care of themselves now,'' said Wilczynski, director of cytology at City of Hope in Duarte. ``The Pap smear has led to a dramatic decrease in cervical cancer over the past 30 years.

``The Pap smear works.''

Currently, doctors in the United States can only conduct HPV tests to help diagnose cervical cancer in women who have had abnormal Pap tests. The test is not approved for general screening of healthy women, either by a doctor or for the at-home, self-collection procedure. Digene officials expect the home test to be available in one to three years in the United States, sooner in Europe.

Once it is approved for at-home use - which requires approval from the U.S. Food and Drug Administration - doctors say the HPV test may open up care to women who are uninsured, live in underdeveloped regions, or are reluctant to visit a gynecologist. At less than $30, the procedure is designed to be ``no more expensive'' than a Pap test, said Digene president Charles Fleischman who expects the HPV test to be fully covered by major insurance carriers. (An annual gynecological exam, considered a preventive service, is typically covered by nearly all insurance carriers, according to Walter Zelman, president of the California Association of Health Plans.)

Also still to be determined is whether women will embrace the concept of performing a necessary at-home test the way they have have taken to breast self-examinations and home pregnancy tests. The convenience of an at-home test won't be worth much, doctors say, if women obtain the results of their test and don't act on the information.

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