The FDA will allow genetic testing company 23andMe to market personal genome reports as a direct-to-consumer test of a person’s ability to metabolize some medications to help inform discussions with healthcare providers.
The FDA has authorized the test to detect 33 variants for multiple genes, and will allow the marketing of the tests with special controls, the agency announced.
The FDA’s decision is the first time it has authorized direct-to-consumer genetic tests for pharmacogenetics, the process of understanding what role, if any, genetics play in a patient’s reaction to drugs. The Personal Genome Service test looks at DNA from saliva samples, and the report then describes if a person has variants that may be associated with the ability to metabolize some medicines.
The test is not meant to provide information about a patient’s ability to respond to any specific medication, and healthcare providers should not make treatment decisions based on the test. The FDA noted that results from the tests should be confirmed with independent pharmacogenetic testing before any medical decisions are made.
23andMe is one of the biggest genetic testing companies that has risen to popularity over the last few years as individuals have become more interested in heritage. Genetic reports can also indicate health risks and traits. The company, along with other genetic testing businesses, agreed to new rules over sharing customers’ DNA with third-party companies in August.
“This test is a step forward in making information about genetic variants available directly to consumers and better inform their discussions with their health care providers. We know that consumers are increasingly interested in genetic information to help make decisions about their health care,” Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in a statement.
To get marketing authorization from the FDA, 23andMe submitted studies on its tests and reports showing the tests have greater than 99 percent accuracy and at least 90 percent user comprehension of the key concepts in the reports. More than 97 percent of users understood they should not use the report to make any changes to treatment without consulting their doctor.
“Pharmacogenetic reports are an important category of information for consumers to get access to and I believe this authorization opens the door for consumers to work with their health providers to better manage their medications,” 23andMe Co-founder and CEO Anne Wojcicki said in a statement.
Amy joined TriMed Media as a Senior Writer for HealthExec after covering home care for three years. When not writing about all things healthcare, she fulfills her lifelong dream of becoming a pirate by sailing in regattas and enjoying rum. Fun fact: she sailed 333 miles across Lake Michigan in the Chicago Yacht Club "Race to Mackinac."