FDA Warns Against Use of Unapproved Genetic Tests
Regulatory News | 01 November 2018 |
A day after approving the first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism from 23andMe, the US Food and Drug Administration (FDA) on Thursday warned against the use of the many genetic tests with unapproved claims to predict responses to medications.
FDA said it has become aware of genetic tests and software programs claiming to predict how a person will respond to a specific medication, such as those used to treat depression, heart conditions, acid reflux and others.
“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,” FDA said.
The agency offers the example of a genetic test claiming to help physicians decide which antidepressant should be used by a specific patient, though FDA noted: “the relationship between DNA variations and the effectiveness of antidepressant medication has never been established.”
FDA also said that in the limited number of cases for which at least some evidence does exist to support a correlation between a genetic variant and drug levels within the body - this is described in the labeling of the FDA-cleared or approved genetic tests and FDA approved medications.
“Changing drug treatment based on the results from such a genetic test could lead to inappropriate treatment decisions and potentially serious health consequences for the patient,” the agency said.
Late Wednesday, FDA did permit marketing, with special controls, of the 23andMe Personal Genome Service Pharmacogenetic Reports test as a direct-to-consumer test for providing information about genetic variants that may be associated with a patient’s ability to metabolize some medications to help inform discussions with a health care provider. FDA is authorizing the test to detect 33 variants for multiple genes.
But Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health, cautioned: “This test should be used appropriately because it does not determine whether a medication is appropriate for a patient, does not provide medical advice and does not diagnose any health conditions.”
The alert from FDA Thursday further cautioned: “FDA is alerting patients and health care providers that claims for many genetic tests to predict a patient's response to specific medications have not been reviewed by the FDA, and may not have the scientific or clinical evidence to support this use for most medications.”
Moving forward, FDA said it is looking into certain test developers that may be inappropriately selling genetic tests for the unapproved uses and will take compliance actions when appropriate.
“We will continue to monitor reports of adverse events associated with this issue and will keep the public informed if significant new information becomes available,” FDA said.
FDA Warns Against the use of Many Genetic Tests with Unapproved Claims to Predict Patient Response to Specific Medications: FDA Safety Communication
FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism
FDA said it has become aware of genetic tests and software programs claiming to predict how a person will respond to a specific medication, such as those used to treat depression, heart conditions, acid reflux and others.
“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,” FDA said.
The agency offers the example of a genetic test claiming to help physicians decide which antidepressant should be used by a specific patient, though FDA noted: “the relationship between DNA variations and the effectiveness of antidepressant medication has never been established.”
FDA also said that in the limited number of cases for which at least some evidence does exist to support a correlation between a genetic variant and drug levels within the body - this is described in the labeling of the FDA-cleared or approved genetic tests and FDA approved medications.
“Changing drug treatment based on the results from such a genetic test could lead to inappropriate treatment decisions and potentially serious health consequences for the patient,” the agency said.
Late Wednesday, FDA did permit marketing, with special controls, of the 23andMe Personal Genome Service Pharmacogenetic Reports test as a direct-to-consumer test for providing information about genetic variants that may be associated with a patient’s ability to metabolize some medications to help inform discussions with a health care provider. FDA is authorizing the test to detect 33 variants for multiple genes.
But Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health, cautioned: “This test should be used appropriately because it does not determine whether a medication is appropriate for a patient, does not provide medical advice and does not diagnose any health conditions.”
The alert from FDA Thursday further cautioned: “FDA is alerting patients and health care providers that claims for many genetic tests to predict a patient's response to specific medications have not been reviewed by the FDA, and may not have the scientific or clinical evidence to support this use for most medications.”
Moving forward, FDA said it is looking into certain test developers that may be inappropriately selling genetic tests for the unapproved uses and will take compliance actions when appropriate.
“We will continue to monitor reports of adverse events associated with this issue and will keep the public informed if significant new information becomes available,” FDA said.
FDA Warns Against the use of Many Genetic Tests with Unapproved Claims to Predict Patient Response to Specific Medications: FDA Safety Communication
FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism
© 2025 Regulatory Affairs Professionals Society.
