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The U.S. Food and Drug Administration sent a letter to privately held gene testing company DNA4Life over the company’s sale of an unapproved direct-to-consumer gene test to predict drug response.
In its letter, the agency said it was unable to identify any FDA clearance for the company’s test. The letter follows 23andMe’s limited relaunch of a series of direct-to-consumer (DTC) tests after the agency ordered the tests off the market.
DNA4Life told Reuters in an earlier interview that it did not believe it needed FDA approval to sell its test.
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In its letter, the FDA said the company’s test appears to meet the definition of a medical device, which requires marketing approval. The agency said the company needs to provide evidence that the device has been approved or information regarding why it believes the test does not require FDA approval.
In a statement sent to Reuters, FDA spokesman Eric Pahon said the FDA believes that “certain types of tests are being appropriately offered through the DTC model, but others may need to demonstrate that they are safe and effective and that appropriate controls are in place to mitigate risks.”
Read full, original post: US FDA sends letter to DNA4Life over consumer gene tests
