At the end of October, FDA granted de novo premarket notification clearance for the first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism.1
Steve Halasey, chief editor, CLP.
The clearance was issued for the Personal Genome Service Pharmacogenetic Report by 23andMe, Mountain View, Calif. The company’s test analyzes DNA from a patient-collected saliva sample and detects 33 variants, on multiple genes, that may be associated with the patient’s ability to metabolize some medications. The test does not describe an association between the detected variants and any specific drug, nor whether a person will or will not respond to a particular drug. Results of the test are intended to inform discussions between patients and their healthcare providers.
“This test is a step forward in making information about genetic variants available directly to consumers and better informing their discussions with their healthcare providers,” said Tim Stenzel, director of FDA’s Office of In Vitro Diagnostics and Radiological Health, in a press release. “We know that consumers are increasingly interested in genetic information to help make decisions about their healthcare. 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 agency’s clearance included criteria for six special controls describing the agency’s expectations for assuring the test’s accuracy, clinical performance, and labeling. Among the controls is the requirement for a labeling statement to warn that the consumer should not use the test results to stop or change any medication.
“Consumers should not use this test to make treatment decisions on their own,” said Stenzel. “Any medical decisions should be made only after discussing the results with a licensed healthcare provider and results have been confirmed using clinical pharmacogenetic testing.”
Underscoring FDA’s instructions about the use of such tests, at the beginning of November the agency issued a safety communication to alert the public about concerns regarding pharmacogenetic tests with unapproved claims to predict an individual’s response to a specific therapeutic drug, where the claims may not supported by clinical evidence (see companion article, “FDA Recommendations on the Use of Genetic Testing”).2 In a press release about the safety communication, Jeffrey Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health, and Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research, wrote:3
We are aware that these types of genetic tests are promoted to predict how a person will respond to specific medications used to treat conditions such as depression, heart conditions, acid reflux and others. They may claim that a specific medication may be less effective or have an increased chance of side effects due to a patient’s genetic variations, or indicate that the healthcare provider can or should change a patient’s medication based on results from these tests.
They note, for example:
FDA is aware of genetic tests that claim results can be used by physicians to identify which antidepressant medication would have increased effectiveness or side effects compared to other antidepressant medications. However, the relationship between DNA variations and the effectiveness of antidepressant medications has never been established.
While some lab sector observers have questioned the need for direct-to-consumer testing that should not be used independently to influence treatment decisions, Shuren and Woodcock express cautious optimism about the future of such testing:
We believe, with more scientific study, there is great potential for pharmacogenetics. We have so much more to learn about the use of these tests for specific medications, what the results mean, and how we can apply the information to improve a patient’s health. While we are committed to supporting innovation in this area, we will also be vigilant in protecting against the potential risks.
Nevertheless, until more such tests have passed FDA review, both consumers and healthcare providers are urged to exercise caution about the use of direct-to-consumer pharmacogenetic testing.
References
- FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism [news release, online]. Silver Spring, Md: FDA, 2018. Available at: www.fda.gov/newsevents/newsroom/pressannouncements/ucm624753.htm?utm_campaign=10312018_pr_fda%20authorizes%20test%20for%20detecting%20genetic%20variants&utm_medium=email&utm_source=eloqua. Accessed November 2, 2108.
- The FDA warns against the use of many genetic tests with unapproved claims to predict patient response to specific medications: FDA safety communication [online]. Silver Spring, Md: FDA, 2018. Available at: www.fda.gov/medicaldevices/safety/alertsandnotices/ucm624725.htm. Accessed November 2, 2018.
- Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, and Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, on agency’s warning to consumers about genetic tests that claim to predict patients’ responses to specific medications [FDA Statement, online]. Silver Spring, Md: FDA, 2018. Available at: www.fda.gov/newsevents/newsroom/pressannouncements/ucm624794.htm?utm_campaign=11012018_pr_fda%20warns%20consumers%20about%20concerns%20with%20pharmacogenetic%20tests&utm_medium=email&utm_source=eloqua. Accessed November 2, 2018.
Steve Halasey
Chief Editor, CLP
[email protected]
(626) 219-0199
