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Home Genetic Tests May Need Doctor's Involvement: Report
Date:3/10/2011

WEDNESDAY, March 9 (HealthDay News) -- Some genetic tests sold directly to consumers that might help to predict health risks may need to be supplied through doctors, a U.S. Food and Drug Administration official said Wednesday, Bloomberg News reported.

The official, Alberto Gutierrez, director of the FDA office that regulates diagnostic screening tools, made the comments to reporters after an agency advisory panel concluded two days of hearings on the increasingly popular tests. The hearings were held to weigh the tests' benefits and risks.

"We're probably not going to be able to take one approach to all the types of tests that the companies want to offer," Gutierrez said, noting that the agency will likely make determinations to restrict the use of the tests on a case-by-case basis, Bloomberg reported. "It depends on the disease and the type of test."

The FDA may require that some genetic tests be ordered by doctors, and some test results may have to be sent to doctors instead of patients, he said. Other tests "may not require a doctor at all," he said.

The tests, their manufacturers contend, can help predict a person's risk for disease or how someone might respond to a given medication.

The advisory panel looked only at those genetic tests sold directly to consumers without the involvement of medical professionals. The kits enable people to have their genetic material analyzed to identify variations that might be related to inherited disorders, such as cystic fibrosis, breast cancer and even Alzheimer's disease.

This relatively new category of tests sprang up as a result of the U.S. Human Genome Project, begun in 1990, which boosted understanding of human health, disease and genetics, the FDA explained in a background summary. Because the field is so new, little is known about the accuracy of home genetic tests or the implications of test results, particularly if a health-care prof
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