Show Biotech firm to offer breast cancer genetic screening Rob Stein The Washington Post PostA PostA PostA A biotech company Wednesday will begin offering the first genetic test to assess a womans woman's risk for forthe forthe forthe the most common forms of breast cancer 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 womans 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 Kari deCODEs deCODE's chief executive what you need to do to tomake tomake tomake make early diagnoses or take preventive measures This test will most definitely save lives While welcomed by some patient advocates and doctors the 1625 test raises concerns among others Some questioned its reliability while others worried the results could either lull women into a aJ aj J j 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 reassure some women and alarm others said Eric Winer a breast cancer expert at Harvard Medical School and 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 Mary King a breast cancer genetics expert at the University of Washington Its 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 more than 1200 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 s said id Joan Scott deputy director of the Center for Genetics and Public Policy r j t. t ti 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 spokesperson 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 aletter aletter aletter letter expressing concern to another company marketing a questionable genetic test for ovarian cancerI cancer I cant can't speculate on this one said Karen Riley the spokesperson Breast cancer strikes more than women each year in the United States and kills more than making it the most common form of cancer after skin cancer and second leading cancer killer among women Doctors can estimate a womans woman's chances of developing breast cancer based on a variety of factors including her age and famil 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 only account for 1 percent to 3 percent of all breast c cancers t I. I I. I I |