The US Food and Drug Administration (FDA) has announced that is has granted 23andMe de novo authorization to offer reports on pharmacogenetics, indicating how customers' genetics may influence the way they metabolise certain medications.
This is the first authorization of a direct-to-consumer report on pharmacogenetics and came through the FDA's de novoclassification process. With this authorisation, the FDA has classified these direct-to-consumer pharmacogenetic reports as moderate risk that have special controls to ensure safety, effectiveness and accuracy. This authorisation 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 authorisation opens the door for consumers to work with their health providers to better manage their medications."
As part of the authorisation 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% of users understood that they should not use the report to make any changes to treatment without consulting their doctor.
The authorisation allows for the reporting of variants in multiple genes that impact how well an individual metabolises 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 authorisation allows 23andMe to provide customers with information on whether they are predicted to be fast or slow metabolisers 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 labelling 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."
This latest FDA authorisation follows several years of work by 23andMe that has led to four separate FDA de novoauthorisations 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% accuracy. Further, 23andMe had to demonstrate at least 90% 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.