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The U.S. Food and Drug Administration (FDA) recently approved the use of a screening
test designed to detect the human
papillomavirus (HPV), a sexually transmitted disease that can increase the risk of cervical cancer. HPV testing has previously been available to women who
have received abnormal Pap test results but not for general screening purposes. The FDA
approval makes the HPV test an option for all women 30 years of age in conjunction with
their annual Pap tests.
The American Cancer Society estimates that in 2003, 13,000 new cases of invasive
cervical cancer will be diagnosed in the United States and approximately 4,100 American
women will die from the disease. Researchers estimate that non-invasive cervical cancer is
nearly four times as likely as invasive cervical cancer. The International Agency for
Research on Cancer estimates that nearly 380,000 women are diagnosed with cervical cancer
worldwide each year. The number of cases and number of deaths from cervical cancer are
higher in less developed countries where routine screening is not widespread.
The human papillomavirus (HPV) is a sexually transmitted disease. There are over 80
different strains of HPV, affecting more than 40 million Americans. While the majority of
HPV strains do not pose health risks, a few strains increase the risk for cervical cancer.
Annual Pap tests help screen women for cervical cancer and have contributed to a 75%
decrease in cervical cancer deaths in the U.S since the mid-1950s.
Because some strains of HPV are linked to cervical cancer, the FDA recently approved
the use of HPV testing for women who receive abnormal Pap test results. Approximately 50
million Pap smears are performed each year in the U.S., and 2 million of the tests produce
unclear results (a result called ASCUS). However, physicians are not able to determine
whether those abnormal results are harmless or signal pre-cancerous conditions. Before the
approval of HPV testing, women with abnormal Pap results received follow up with either
colposcopy (endoscopic viewing the cervix with magnification), with or without biopsy, or
repeat Pap tests. The majority of women who undergo follow-up do not have pre-cancer or
cancer and therefore these procedures turn out to be unnecessary.
Now, the FDA has approved HPV testing for all women 30 years of age and older in
conjunction with yearly Pap tests. According to Digene Corporation, the company that makes
the FDA approved HPV test, this screening could help reassure women with abnormal Pap
tests and negative HPV tests that their short-term risk of cervical cancer is low.
According to Digene, approximately 50% of women with abnormal Pap test results (ASCUS)
receive HPV testing as a follow up, and 90% of those women receive reimbursement from
their health insurance for the HPV test. Digene says it is working with the FDA to obtain
reimbursement for women who will now receive HPV screening tests.
HPV testing can also help alert physicians to women at risk for cervical cancer.
"This [FDA} decision represents a major advancement in the fight against cervical
cancer, offering women and their physicians the first objective screening measure of a
woman’s risk for cervical cancer," said Evan Jones, Digene’s Chairman and
Chief Executive Officer, in a news release. "We are extremely excited by the
FDA’s decision. With our hc2 HR HPV Test, when used in conjunction with the Pap test,
doctors can detect cervical disease and its precursors earlier than ever before."
The risk of cervical cancer is greater for women in their thirties, and therefore, the
HPV screening test is not approved for younger women. Pap tests are available for these
younger women and are still recommended for all women. Most physicians recommend that all
women begin receiving yearly Pap tests and pelvic examinations at age 18 or when they
become sexually active, whichever occurs earlier. Some physicians will not perform a Pap
test each year if a woman has had three negative Pap tests in the course of three years.
However, a yearly pelvic exam should be continued even if Pap tests are not given each
year.
Nevertheless, cervical cancer remains relatively rare in the United States, where
screening is widespread. Symptoms that may be associated with cervical cancer include
unusual vaginal discharge, vaginal bleeding, or bleeding or pain during sexual
intercourse.
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