Pharmacogenetics is emerging as an important field to understand how genetic differences affect an individual’s ability to metabolize drugs. Now, genetic testing company 23andMe has been given the go-ahead by the FDA to offer pharmacogenetics reports to their customers.
“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 approval was made through the regulator’s de novo pathway which will allow 23andMe to inform consumers on their variant status when it comes to genes involved in multiple drug metabolism pathways. The direct-to-consumer test results have been classified as moderate risk based on the accuracy of the tests as well as the potential for the results to influence consumers’ health decision-making.
Of concern to the FDA was whether receiving these pharmacogenetic results would cause patients to stop taking their medications as prescribed, potentially interfering with their adherence to important drugs. According to 23andMe, their surveys found that 97 percent of those who had used the service would not change their medication regime as a result of the report without consulting a doctor first.
The genes that 23andMe plans to report on are involved in the metabolism of over 50 medications, some of which are available by prescription with others being purchased over-the-counter. Since pharmacogenetics can identify whether a patient is more likely to slowly or quickly metabolize a drug – and can even predict whether they’ll respond to certain medications at all – the results of these tests could help patients and their doctors make more informed treatment decisions, particularly when it comes to drugs already labeled with pharmacogenetic information.
“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.”
23andMe has been benefiting from multiple FDA approvals this year, with the regulator previously allowing the genetic testing company to report on BRCA gene variant status and cancer risk. Still, the company says it’s uncertain when it will start reporting on pharmacogenetic results to consumers.