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Wednesday
Mar092011

The FDA Weighs In on Over-the Counter Genetic Tests

Photodisc/Thinkstock(WASHINGTON) -- Scientific advances now let us buy genetic testing kits over-the-counter, but the results may be confusing without professional advice.  Now the government is taking a closer look.

The U.S. Food and Drug Administration wants to know what the risks are when consumers use genetic tests they buy over-the-counter.  They include tests that look for inherited disease, predict the risk of future disease, and predict a patient's response to specific drugs.

The test results are typically sent directly to the customer without being evaluated by a clinician.

The government is asking a panel of outside experts:

-- What are the risks and benefits of direct public access to such tests?

-- What do you do about test results that are false, incomplete, misleading or too complicated for a lay person to understand?

-- The FDA requires scientific evidence to determine whether home-use tests are safe and effective.  Since results of home genetic tests may be used in many ways, should evidence requirements vary with the claims made for the various tests?

The study will not involve tests that make no medical claims, such as genealogical or forensic tests.

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