The Food and Drug Administration (FDA) has granted 23andMe clearance for its CYP2C19 Drug Metabolism Report for interpretive drug information of 2 medications – clopidogrel and citalopram.
The 510(k) clearance allows for modification of the labeling of the previously authorized pharmacogenetics report. The modified labeling removes the need for confirmatory testing and provides interpretive drug information direct-to-consumer based on genetic factors for these specific medications.
The pharmacogenetics report provides information on CYP2C19 variants that may impact the metabolism of clopidogrel and citalopram. Treatment of individuals with these variants may result in reduced efficacy and/or increased adverse reactions that could potentially be life-threatening. According to 23andMe, more than half of its 2 million customers were found to have at least 1 CYP2C19 variant that could affect the metabolism of clopidogrel or citalopram.
The FDA required rigorous analytical validation from the Company in order to remove the need for confirmatory testing, including method comparison studies with expanded sample collection activities; accuracy testing was found to exceed 99% concordance with Sanger sequencing.
“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, a P2Y12 platelet inhibitor, is indicated for the treatment of acute coronary syndrome and in patients with recent myocardial infarction, stroke or established peripheral arterial disease to reduce the rate of MI and stroke.
Citalopram, a selective serotonin reuptake inhibitor, is approved for the treatment of depression.
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23andMe granted new FDA clearance to provide interpretive drug information for two commonly prescribed medications. https://www.prnewswire.com/news-releases/23andme-granted-new-fda-clearance-to-provide-interpretive-drug-information-for-two-commonly-prescribed-medications-301114145.html. Accessed August 18, 2020.