The idea that genetic information is different from other medical information and therefore needs special protection has led to a regulatory puzzle where genetic testing is currently regulated under three separate schemes. Although genetic tests for over 2,000 diseases are available, less than 10% of these tests have been reviewed for clinical validity or utility. Recent action by some genetic testing companies has prompted the federal government to propose changes to the current regulatory scheme. This article discusses the current framework and the recent developments before examining some of the concerns and challenges that face the implementation of these proposed changes. The author evaluates the proposals and competing interests in order to suggest how genetic testing may best be regulated to meet the needs of the industry, clinicians, researchers, patients, and consumers.

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