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FDA Weighs Pros, Cons of Home Genetic Testing
Date:3/8/2011

TUESDAY, March 8 (HealthDay News) -- The U.S. Food and Drug Administration began a two-day hearing Tuesday to weigh the risks and benefits of those increasingly popular direct-to-consumer genetic tests.

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

A panel of FDA advisers will look 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.

While the FDA isn't compelled to follow the recommendations of its advisory panels, it usually does so.

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 released Tuesday. 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 professional isn't involved to help consumers interpret the results.

Currently, only home tests that make medical claims are regulated by the agency.

Last year, Pathway Genomics announced that it would start selling tests (in general, the test can cost from $400 to $2,000) at Walgreens stores, which are ubiquitous in the United States. Walgreens reversed its decision, however, after the FDA raised questions about the supplier.

Before drafting regulations for the direct-to-consumer tests, the FDA has asked its advisers and test manufacturers for input in a variety of areas, including the reliability of the tests; the possibilities for misuse; the likelihood -- and consequences -- of misunderstood results; and how a lack of counseling might a
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