23andMe to offer direct-to-consumer pharmacogenetics reports
The Food and Drug Administration has granted consumer genetics and research company 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. 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," 23andMe co-founder and CEO Anne Wojcicki said in a statement. "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 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 company said.
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 23andMe 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.
Finally, the company said that 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.
This is the first authorization of a direct-to-consumer report on pharmacogenetics and came through the FDA's de novo classification process. 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," 23andMe co-founder and CEO Anne Wojcicki said in a statement. "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 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 company said.
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 23andMe 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.
Finally, the company said that 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.