The FDA is quietly cracking down on genetic testing companies

Among the swaths of information you can learn from consumer genetics companies is whether your DNA might make it unwise to take certain drugs. Now, thanks to a backchannel effort from the FDA, those results are being quietly deleted from companies’ reports.

As STAT’s Rebecca Robbins reports, a handful of genetic testing companies confirmed that they’ve made changes to their test results after months of discussions with the FDA. Regulators worried that unsupported claims about gene-drug links could convince customers to start, stop, or switch medications without a viable medical reason.

The sudden regulatory scrutiny caught the nascent industry by surprise, and the Precision Medicine Coalition, a trade group that represents genetic testing firms, is planning to sit down with FDA officials to better understand what might be expected in the future.

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