A  A  A   Print
FDA Warns Against Nipple Test for Breast Cancer Screening

FDA Warns Against Nipple Test for Breast Cancer Screening

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 specialist.

"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 cervical cancer.

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.

More information

The U.S. National Cancer Institute has more about breast cancer screening.

SOURCE: U.S. Food and Drug Administration, news release, Dec. 12, 2013

 
Today's Interactive Tools
Related Items

The third-party content provided in the Health Library of phoebeputney.com is for informational purposes only and is not designed to diagnose or treat a health problem or disease, or replace the professional medical advice you receive from your physician. If you or your child has or suspect you may have a health problem, please consult your primary care physician. If you or your child may have a medical emergency, call your doctor or 911 or other emergency health care provider immediately in the United States or the appropriate health agency of your country. For more information regarding site usage, please visit: Privacy Information, Terms of Use or Disclaimer.

Follow us online:

© 2014 Phoebe Putney Health System  |  417 Third Avenue, Albany, Georgia 31701  |  Telephone 877.312.1167

Phoebe Putney Health System is a network of hospitals, family medicine clinics, rehab facilities, auxiliary services, and medical education training facilities. Founded in 1911,
Phoebe Putney Memorial Hospital (the flagship hospital) is one of Georgia's largest comprehensive regional medical centers. From the beginning, Phoebe's mission and vision
has been to bring the finest medical talent and technology to the citizens of Southwest Georgia, and to serve all citizens of the community regardless of ability to pay.