23andMe Granted The First and Only FDA Authorization For Direct-to-Consumer Pharmacogenetics Reports

The U.S. Food and Drug Administration (FDA) granted 23andMe authorization to offer reports to customers on pharmacogenetics, indicating how customers’ genetics may influence the way they metabolize certain medications.

 

The decision marks the first time the FDA has authorized a direct-to-consumer genetic test for pharmacogenetics.

 

“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.””

 

The authorization allows for the reporting of variants in multiple genes that impact how well an individual metabolizes certain medications, for example clopidogrel, which is commonly prescribed to prevent heart attacks and strokes. These genes are associated with response to more than 50 other commonly prescribed and over the counter medications. The authorization allows us to provide customers with information on whether they are predicted to be fast or slow metabolizers based on their genetics, and when supported by appropriate clinical evidence, whether they may experience reduced efficacy or have an increased chance of side effects from certain medications.  

 

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.

 

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.

User comprehension was an important part of the FDA’s evaluation of the pharmacogenetics reports. In this case it was not just looking to ensure that consumers understand the reports but also at “treatment adherence” — whether or not a customer would stick to their prescribed treatment of a medication or whether a report would lead them to change or stop treatment. Our study 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.

 

Finally, the decision continues the commitment made by 23andMe to return all the types of genetic health information to customers that it offered before received an FDA warning letter in 2013.