Firm Says Test Judges Risk For Common Breast Cancers

By Rob Stein
Washington Post Staff Writer
Wednesday, October 8, 2008

A biotech company today will begin offering the first genetic test to assess a woman's risk for the most common forms of breast cancer, reigniting debate about the growing number of unregulated genetic tests.

The test by Decode Genetics of Reykjavik, Iceland, a respected pioneer in genetic research, promises to determine a woman's risk through a simple blood sample or cheek swab. Previously, the only tests for breast cancer risk were for relatively rare genes, leaving most women with no way to assess their individual genetic predisposition.

"What this does for women is allow them to assess their personal risk for the common forms of breast cancer," said Kári Stefánsson, Decode's chief executive. "That's what you need to do to make early diagnoses or take preventive measures. This test will most definitely save lives."

While welcomed by some patient advocates and doctors, the $1,625 test raises concerns among others. Some questioned its reliability, while others worried that the results could either lull women into a false sense of complacency or needlessly alarm them, prompting them to take unnecessary tests or even undergo unneeded surgery.

"There is at least a significant chance this test will could falsely reassure some women and alarm others," said Eric Winer, a breast cancer expert at Harvard Medical School and a spokesman for the American Society of Clinical Oncology. "I fear for many women the results could be quite misleading."

"I wouldn't recommend to anyone that she have such a test. I certainly wouldn't want my daughter to have such a test," said Mary-Claire King, a geneticist and breast cancer expert at the University of Washington. "It's meaningless, and it could very easily introduce real confusion."

The test comes as concern has been rising about the proliferation of genetic tests. Hundreds of laboratories are now offering genetic testing for more than 1,200 conditions. The Food and Drug Administration does not regulate such tests when they are performed by the labs offering them.

"There is concern about the validity of many genetic tests that are being offered," said Joan Scott, deputy director of the Center for Genetics and Public Policy at Johns Hopkins University. "Without an external review, the consumer -- be it the physician or the patient directly -- is not going to know which ones have been validated."

An FDA spokeswoman said the agency had just become aware of the new test and could not say whether it would take any action, though she noted that in August the agency sent a letter expressing concern to another company marketing a questionable genetic test for ovarian cancer.

"I can't speculate on this one," said Karen Riley, the spokeswoman.

Breast cancer strikes more than 180,000 women each year in the United States and kills more than 40,000, making it the most common form of cancer after skin cancer and second leading cancer killer among women.

Doctors can estimate a woman's chances of developing breast cancer based on a variety of factors, including her age and family history, but most women have no way of knowing their precise risk. Women with a strong family history can get tested for two genes that sharply increase their predisposition, but they account for only 1 to 3 percent of all breast cancers.

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