The decision allows 23andMe to report directly to customers, without a prescription, the influence their genetics have on how well they metabolize certain medications
(Updated Nov. 1, 2018 2:30 PM PST: This release has been updated to include new information from the FDA)
Mountain View, California – October 31, 2018 (Updated Nov. 1, 2018 2:45 PM PST) – In another first, the U.S. Food and Drug Administration (FDA) granted 23andMe de novo authorization to offer reports on pharmacogenetics, indicating how customers’ genetics may influence the way they metabolize certain medications.
This is the first authorization of a direct-to-consumer report on pharmacogenetics, and came through the FDA’s de novo classification process. With this authorization, the FDA has classified these direct-to-consumer pharmacogenetic reports as moderate risk that have special controls to ensure safety, effectiveness and accuracy. This authorization enables 23andMe to report on numerous variants associated with pharmacogenetic response.
“We’ve continued to innovate through the FDA and pioneer safe, effective pathways for consumers to directly access genetic health information,” said 23andMe co-founder and CEO Anne Wojcicki. “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.”
As part of the authorization process 23andMe had to demonstrate the accuracy of its testing and consumer comprehension of the testing information, including “treatment adherence” and whether or not a customer would continue their prescribed treatment of a medication, or change or stop treatment. Studies showed that more than 97 percent of users understood that they should not use the report to make any changes to treatment without consulting their doctor.
This authorization allows 23andMe to report variants in multiple genes that are associated with how an individual may metabolize some medications. It enables 23andMe to provide customers with information on whether they are predicted to be fast or slow metabolizers based on their genetics, but does not describe associations between any detected genetic variants and any specific medication. The new regulation will allow for future FDA submissions to seek authorization to report whether an individual with certain genetic variants may experience reduced efficacy or increased chance of side effects from certain medications, when supported by appropriate clinical evidence.
It has long been established that genetics influence how people respond to different medications. Certain medications have for many years included labeling with pharmacogenetics information — the FDA started listing these in 2009 — but patients often only learn that they process a medication differently after they begin taking it.
“We believe it’s important that all consumer genetic health tests should be going through the FDA and subject to the same rigorous testing that 23andMe undergoes,” said Wojcicki. “It is concerning that the FDA is not requiring all direct-to-consumer genetic testing services to meet the high bar for analytical validity, accuracy or user comprehension, which 23andMe does. It’s confusing for consumers that this double standard exists.”
Today the FDA issued a safety alert warning consumers and physicians about pharmacogenetic tests whose claims have not been reviewed by the FDA, but are being sold directly to consumers. FDA also published a website about direct-to-consumer tests that indicates which tests have FDA marketing authorization.
This latest FDA authorization follows several years of work by 23andMe that has led to four separate FDA de novo authorizations for direct-to-consumer genetic tests for carrier status, genetic health risk reports, select BRCA1 and BRCA2 variants and now pharmacogenetic reports. Each has included an extensive FDA review process in which 23andMe was required to submit studies demonstrating that our reports are scientifically valid and understandable for consumers, and that the results are analytically reliable. In order to demonstrate this, 23andMe showed its tests have greater than 99 percent accuracy. Further, 23andMe had to demonstrate at least 90 percent user comprehension of the key concepts communicated in the reports.
Finally, the decision continues the commitment made by 23andMe to return all the types of genetic health information to customers that it offered prior to an FDA warning letter in 2013. However, 23andMe has not determined when it will be able to make these new reports available to its customers.
23andMe, Inc. is the leading consumer genetics and research company. Founded in 2006, the mission of the company is to help people access, understand, and benefit from the human genome. 23andMe has millions of customers worldwide, with more than 80 percent of customers consented to participate in research. 23andMe, Inc. is located in Sunnyvale, CA. More information is available at www.23andMe.com.