SMRs and AMRs

Friday, January 18, 2008

Growth of Genetic Tests Concerns Federal Panel

By ROBERT PEAR
New York Times

WASHINGTON — The science of genetic tests is marching ahead and so are efforts to sell them directly to consumers who are willing to send in a check and a bit of saliva to learn whether they are at risk for a disease.

What is not keeping up is regulation and oversight, according to a federal advisory panel. The panel concluded that a growing number of the tests are being marketed with claims that are unproved, ambiguous, false or misleading.

Millions of people have already taken the tests, a relatively new tool that even many doctors have yet to master. Test results can provide information to help prevent, detect and treat hundreds of conditions including cancer, heart disease, diabetes, cystic fibrosis and blood disorders.

The results can lead to momentous decisions. For example, women with a family history of breast cancer rely on them in deciding whether to have surgery to remove breasts or ovaries as a preventive measure.

With use of the tests growing at an explosive rate, the panel concluded that patients could be harmed. In most cases, the tests do not pose a direct physical risk; but, the panel said, if a test is inaccurate, patients may be given risky, unnecessary treatments or denied treatments that would be highly beneficial.

(Continued here.)

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