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The Washington Post

Doctors Endorse Digene Test
Cervical Cancer Screen Builds on Pap Smear

By Michael Barbaro
Washington Post Staff Writer
Friday, August 1, 2003; Page E01

Shares of Digene Corp. vaulted 20 percent yesterday after an
influential group of doctors recommended the Gaithersburg company's
newly approved cervical cancer test as a primary screening mechanism
for women over 30, a move expected to accelerate usage and insurance
coverage.

In its most comprehensive revision of cervical cancer screening
guidelines in more than a decade, the American College of
Obstetricians and Gynecologists backed the use of Digene's two-in-one
examination, which combines the standard Pap test with a genetic test
for the cancer-causing human papillomavirus, or HPV.

The group did not endorse Digene's test over the Pap, a visual exam of
cervical cells. Rather, it recommended both tests as acceptable
screening options. But under the new guidelines, women over age 30 who
test negative with Digene's test, called the DNA With Pap, will
require fewer tests before they can begin skipping an annual
screening.

The physicians group said that women over 30 who test negative for
cancer and precancerous changes on three consecutive annual Pap tests
can wait up to three years for a rescreening. Women over 30 who test
negative for the same conditions just once with the DNA With Pap test
can also wait three years, and perhaps longer, for a rescreening.

Women who test positive with either Digene's combined test or the
Pap-only test will require more frequent screening, and in some cases,
a far more invasive colposcopy or biopsy. Federal regulators have not
approved and do not recommend Digene's combined test for women under
30 because HPV, an extremely common sexually transmitted virus, does
not pose a serious health risk to that population.

Digene president and chief financial officer Charles M. Fleischman
said the guidelines would likely hasten adoption of the combined test,
which has in the past met resistance from gynecologists, who fear it
will discourage annual checkups, and from women, who are far more
familiar with the 50-year-old Pap.

The group's new guidelines are also expected to trigger broader
insurance coverage for the test, which is more expensive than the Pap.
Digene's combined test will cost at least $50 to $60, the company
said, compared with $14 to $30 for a Pap-only test.

Shares of Digene yesterday closed at $32.82, up $5.55.

The Food and Drug Administration approved Digene's combined test as a
primary cervical cancer screen four months ago. It was previously
cleared only to test women who had abnormal Pap-test results. The test
combines the Pap test with a genetic exam for 13 strains of HPV, which
together cause 99 percent of cervical cancer cases. Like the Pap test,
it is performed by collecting cells from the cervix and sending them
to a laboratory for analysis.

But when combined with the Pap, Digene's HPV test significantly
increases doctors' odds of detecting and treating a disease that kills
at least 4,000 American women a year, medical experts say.

"If both the Pap and HPV test are negative, women can have an extra
level of comfort they will not get cervical cancer in the next three
years," said Alan G. Waxman, professor of obstetrics and gynecology at
the University of New Mexico School of Medicine and the principle
author of the guidelines.

But Digene's combined test is not without its critics. Many
gynecologists worry it could create confusion in cases where HPV is
found but is not considered a danger. A number of physicians groups
are developing guidelines to address that situation.

© 2003 The Washington Post Company