510(k) Clearance allows 23andMe to report interpretive drug information for medications prescribed for heart conditions and depression without the need for confirmatory testing
SUNNYVALE, California – August 18, 2020 – The U.S. Food and Drug Administration (FDA) granted 23andMe 510(k) clearance for a pharmacogenetics (PGt) report for interpretive drug information for two medications – clopidogrel, prescribed for certain heart conditions, and citalopram, prescribed for depression. The 510(k) clearance modifies the labeling of the previously authorized 23andMe CYP2C19 Drug Metabolism Report, removing the need for confirmatory testing and allowing the company to provide interpretive drug information based on genetic factors for these specific medications.
“This expanded indication for our Pharmacogenetics report recognizes the accuracy of our results and enables doctors to use them in prescribing therapies,” said Anne Wojcicki, co-founder, and CEO of 23andMe. “This is a great milestone in making personalized medicine a reality.”
Clopidogrel is commonly prescribed to prevent serious or life-threatening problems with the heart and blood vessels in people who have had a stroke, heart attack, or severe chest pain. Citalopram is used to treat depression and is in a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs). Individuals with certain genetic variants impacting drug metabolism by the CYP2C19 enzyme may experience reduced efficacy and/or increased chances of side effects from these medications, which could lead to life-threatening adverse events, such as cardiac problems.
This clearance allows 23andMe to give consumers information to share with their doctors through accurate variant detection and clinically validated pharmacogenomic associations, consistent with the FDA-approved drug labels for both of these medications.
“This is impactful pharmacogenetic information that can now be delivered without the need for confirmatory testing, a testament to the clinical validity of 23andMe results,” said Kathy Hibbs, 23andMe Chief Legal, and Regulatory Officer. “23andMe remains the only company with direct-to-consumer pharmacogenetic reports cleared by the FDA. Now that we have pioneered a regulatory path, we believe all companies marketing pharmacogenetic reports should go through the FDA review process to ensure the safety and effectiveness of their tests.”
23andMe underwent rigorous analytical validation in order to meet FDA requirements and remove the need for confirmatory testing of the 23andMe pharmacogenetics report for CYP2C19. This included rigorous method comparison studies with expanded sample collection activities in order to increase the likelihood of obtaining rare *3 allele combinations and further mitigate the risk for false-positive / negative results. Accuracy testing exceeded 99% concordance with Sanger sequencing.
As with its previously authorized pharmacogenetics reports, both 23andMe and the FDA also want to ensure that consumers understand these reports and use them properly, which includes adhering to their current medications and consulting with their healthcare providers. Based on 23andMe’s previous consumer comprehension studies, over 95 percent of users understood that they should not use the report to make any changes to treatment without consulting their doctor.
This new interpretive drug information report may be particularly impactful because of how common CYP2C19 variants are. Looking at data from more than 2 million 23andMe customers from diverse ethnic backgrounds who consented to participate in research, 23andMe scientists recently found that more than half had at least one CYP2C19 variant that could alter how their bodies metabolize clopidogrel and citalopram.
These PGt reports add to the health-related reports offered direct-to-consumer by 23andMe that should be eligible, based on a 2019 IRS ruling, for reimbursement using Flexible Spending Account (FSA) and Health Savings Account (HSA) funds.
 https://medlineplus.gov/druginfo/meds/a601040.html (MedlinePlus, National Institutes of Health resource on medication)
 https://medlineplus.gov/druginfo/meds/a699001.html (MedlinePlus, National Institutes of Health resource on medication)
 https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0d010775-1160-4b2e-a928-563a02edd191 (DailyMed, National Library of Medicine, clopidogrel)
 https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cf7b6823-108b-ebff-8f41-91f8b8325e3a (DailyMed, National Library of Medicine, citalopram)
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.