This week, the U.S. Food and Drug Administration (FDA) granted 23andMe a 510(k) clearance for a pharmacogenetics report on two medications, clopidogrel, prescribed for certain heart conditions, and citalopram, which is prescribed for depression.
The decision this week modifies the labeling of the previously authorized CYP2C19 Drug Metabolism report which was granted FDA authorization in 2018. The new 510(k) clearance for the pharmacogenetics report for CYP2C19 modifies the labeling to remove the need for confirmatory testing and allows 23andMe to report interpretive drug information for two medications.
“This impactful pharmacogenetics information 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.”
The clearance follows what was a rigorous analytical validation process necessary to meet FDA requirements. This process included method comparison studies with expanded sample collection activities in order to increase the likelihood of obtaining certain rare allele combinations. This further mitigated the risk of false-positive or false-negative results. Accuracy exceeded 99 percent agreement with Sanger sequencing, which is considered the clinical ‘gold standard’ for testing.
Besides analytical validity, 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.
In its clearance decision, the FDA found that: “As presented, the modified pharmacogenetic report for CYP2C19, without the confirmatory testing requirement, is a safe and effective consumer product that can safely and effectively assist customers with certain CYP2C19 genotypes in understanding how their body may respond to certain medications and encourage informed conversations with their healthcare provider.”
The report looks at two commonly prescribed medications. Clopidogrel is used to prevent serious or life-threatening blood clots 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 in the CYP2C19 gene may metabolize these medications differently and experience reduced efficacy and/or increased chances of side effects from these medications.
People with certain genetic variants who are taking clopidogrel or citalopram have a higher risk of serious adverse events, such as life-threatening cardiac events.  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.
These new medication response reports 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.
 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)