FDA Warns Genetic Tests for Consumers Are Unapproved

Warning to five companies, including a Google-backed firm

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The Food and Drug Administration is warning companies making genetic tests for consumers, including one backed by Google, that the agency requires more regulatory approval before such tests can be marketed to the public.

The letters to five companies, including Google-backed 23andMe, don’t mandate that the tests be pulled, since the FDA had not made clear to the companies what type of approval was required before the companies began selling their products.

“23andMe has never submitted information on the analytical or clinical validity of its tests to FDA for clearance or approval,” the FDA wrote in the letter to that company. “However, your website states that the 23andMe Personal Genome Service is intended to tell patients in advance how they will respond to certain medications including warfarin and clopidogrel.”

(MORE: Time Out: Behind the FDA’s Decision to Halt Direct to Consumer Genetic Testing)

23andMe sells a test that can provide genetic analysis from an individual’s saliva. Other companies, such as Navigenics and deCODE Genetics, which also received letters, look at specific genetic variations that have been linked to diseases such as cancer or diabetes.

The FDA said the genetic tests are medical devices that need premarket approval before they can be sold to consumers. Such oversight includes “an independent and unbiased assessment of a diagnostic test’s ability to generate test results that can reliably be used to support good health care decisions,” the agency said in the letters.

23andMe officials have argued in the past that their services provide only information, and not diagnoses, and that because their tests are conducted by a single laboratory, and are not kits that can be used by any laboratory or hospital, that these should not be regulated as devices.

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