FDA Issues Warning Regarding Certain Genetic Tests

Ability to predict patient response to medications often unproven

Ohe FDA issued a cautionary statement intended for patients and providers warning against over reliance upon genetic testing to determine the potential effectiveness of certain medications.

“The FDA is also aware of software programs that interpret genetic information from a separate source that claim to provide this same type of information,” read the statement. “However, sufficient clinical evidence is not currently available for these genetic tests or software programs and, therefore, these claims are not supported for most medications.”

Clarification was offered for those tests that do come with some level of approval or scientific backing, and the FDA made it clear that such tests are backed by labeling of such FDA approvals.

The Administration’s advice for patients:

  • Do not change or stop taking any medicine based on a report from a genetic test you took on your own.
  • Be aware that most genetic tests that make claims about the effects of a specific medicine are not supported by enough scientific information or clinical evidence.

Advice for providers:

  • Be aware that for most medications, the relationship between DNA variations and medications effects has not been established.
  • Be aware that most genetic tests that make claims regarding effects of a specific medication have not been evaluated by the FDA.


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