FDA allows for expanded marketing of 23andMe to include medication metabolism
The FDA expanded the approved marketing of the 23andMe Personal Genome Service Pharmacogenetic Reports test to include information about 33 genetic variants that may be linked with a patient’s ability to metabolize some medications to help inform discussions with a health care provider, according to an agency press release.
“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 FDA’s Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in the release.
The FDA said it granted the expansion based on data that the 23andMe’s manufacturer provided to show that the test is accurate and provides reproducible results.
This announcement is the latest within the past several past years that expands the use of the 23andMe test and genetic information in health care.
In 2014, 23andMe and Pfizer teamed up to study potential genetic factors associated with Crohn’s disease and ulcerative colitis. A year later, 23andMe began enrollment into a genomic study of patients with systemic lupus erythematosus in collaboration with Pfizer and the Lupus Research Institute.
In 2017, the FDA authorized marketing of 23andMe for 10 diseases and conditions, including Alzheimer’s disease, Parkinson’s disease and celiac disease. Then in March of this year, the FDA authorized more marketing for the 23andMe test, this time for three mutations of BRCA1 and BRCA2 most common among people of Eastern European Ashkenazi Jewish descent.
Increasingly, use of genetic information as a means to estimate disease risk is finding its way into health care. In July, Geisinger Health System began giving its patients the option of having their blood drawn to see if they have any gene variations that cause heart disease and early-stage cancers, but not diseases considered nonactionable. Healio has also previously reported on ways that could potential make the most of direct-to-consumer genetic testing, including discussing goals and limitations with patients seeking to use these tests.
Despite the stream of new uses for genetic information, other FDA officials cautioned that not all genetic tests are alike and urged everyone to investigate any such tests’ claims cautiously.
“We are warning consumers about many such genetic tests being marketed directly to consumers or offered through health care providers that claim to predict how a patient will respond to specific medications. Tests that make such claims that have not been evaluated by the FDA and are not supported by prescribing recommendations in the FDA-approved drug label, may not be supported by scientific and clinical evidence, and may not be accurate,” 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 said in a separate press release.
“We note our concern about health care providers and patients inappropriately selecting or changing drug treatment based on the results from insufficiently substantiated genetic tests, which could lead to potentially serious health consequences for patients. For example, a patient may change the dose of their medication for a particular condition or disease based on the results of an unproven genetic test, which may result in inadequate care or worsening illness,” they added.- by Janel Miller
Disclosures: Stenzel, Shuren and Woodcock all work for the FDA.