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The Murky Regulatory Arena of Genetic Testing

Executive Summary

The FDA has undertaken several measures to make the regulatory process less burdensome for diagnostics companies, but these may not be enough to incentivize companies to take their new genetic tests through the approval process. At the same time, confusion reigns: a special HHS advisory committee on genetic testing has been disbanded, and the FDA is reviewing its jurisdiction to regulate home brews, which are the dominant route to commercialization for genetic tests. Some critics worry that these developments may stifle innovation and companies are waiting for clarity.
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