-- Robert Preidt
FRIDAY, Dec. 13, 2013 (HealthDay News) -- A new test marketed as
an alternative to a mammogram for breast cancer detection is not an
effective screening TOOL, U.S. health officials say.
With the nipple aspirate test, a breast pump collects fluid from
a woman's nipple. The fluid is then examined for abnormal and
potentially cancerous cells. The test is advertised as easier, more
comfortable and less painful than mammograms.
However, there is no proof to support claims that the test can
detect breast cancer, said Dr. David Lerner, a medical officer at
the U.S. Food and Drug Administration and a breast imaging
"FDA's concern is that the nipple aspirate test is being touted as a standalone tool to screen for and diagnose breast cancer as an alternative to mammography," Lerner said in an agency news release. "Our fear is that women will forgo a mammogram and have this test instead."
Skipping a mammogram could put a woman's health and life at risk
if breast cancer goes undetected, Lerner warned.
He said there is no scientific evidence that the nipple aspirate
test, when used on its own, is an effective screening tool for
breast cancer or any other medical condition. The test is still
being studied to determine if it might be useful in combination
with other methods to screen for disease.
"The bottom line is that women should not rely solely on these nipple aspirate tests for the screening or diagnosis of breast cancer," Lerner said. "Mammography is still the gold standard."
In October, Atossa Genetics pulled its nipple aspirate test --
called the ForeCYTE Breast Health Test -- off the market after
being warned by the FDA that its claims about the test were
unsubstantiated. The company claimed the test was "literally a Pap
smear for breast cancer." Pap smears are a standard test for
Women who have had a nipple aspirate test as a form of breast
cancer screening should also have a mammogram, according to
screening guidelines or as recommended by their doctor. Also, they
should talk to their doctor about whether additional tests are
needed, the FDA said.
One in eight U.S. women will develop breast cancer in her
lifetime. The disease is the second leading cancer killer of women
in the country.
The U.S. National Cancer Institute has more about
breast cancer screening.
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