{"entity":{"id":"23andme","kind":"company","name":"23andMe","aka":["23andMe, Inc.","23AndMe","23andMe Personal Genome Service"],"tldr":"23andMe sells a saliva-based genetic test directly to consumers, and three of its cancer risk reports (BRCA1 and BRCA2, MUTYH, HOXB13) are authorised by the US regulator.","summary":"The Personal Genome Service genotypes saliva DNA and reports selected variants. FDA records name 23andMe of Mountain View, California, as the requester of De Novo DEN170046 (BRCA1/BRCA2 selected variants, 2018), which created the cancer predisposition risk assessment device type (21 CFR 866.6090, product code QAZ), and of 510(k) clearances K182784 (MUTYH-associated polyposis, 2019), K211499 (HOXB13 hereditary prostate cancer, 2022) and K223597 (BRCA1/BRCA2 expanded to 44 variants, 2023).","asOf":"2026-11-04","links":[{"label":"23andMe","url":"https://www.23andme.com/"},{"label":"FDA De Novo DEN170046","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN170046"},{"label":"FDA 510(k) K223597","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223597"}],"tags":["gap-fill"],"related":[],"cancers":[],"sections":["diagnostics","prevention"],"technologies":["germline-testing"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["hereditary-cancer-syndromes"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Corporate events after 2023 (ownership, bankruptcy proceedings) were not read in this round and are not recorded."],"hq":"Mountain View, California","country":"US","companyType":"diagnostics","website":"https://www.23andme.com/","investors":[],"funding":[]},"route":"/companies/23andme/","neighbours":{"section":[{"id":"diagnostics","kind":"section","name":"Diagnostics & Biomarkers","route":"/fronts/diagnostics/"},{"id":"prevention","kind":"section","name":"Prevention & Risk","route":"/fronts/prevention/"}],"technology":[{"id":"germline-testing","kind":"technology","name":"Germline (hereditary) testing","route":"/technologies/germline-testing/"}],"term":[{"id":"hereditary-cancer-syndromes","kind":"term","name":"Hereditary cancer syndromes","route":"/terms/hereditary-cancer-syndromes/"}],"drug":[{"id":"23andme-brca-report","kind":"drug","name":"23andMe Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)","route":"/drugs/23andme-brca-report/"},{"id":"23andme-mutyh-report","kind":"drug","name":"23andMe Genetic Health Risk Report for MUTYH-Associated Polyposis","route":"/drugs/23andme-mutyh-report/"},{"id":"23andme-hoxb13-report","kind":"drug","name":"23andMe Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)","route":"/drugs/23andme-hoxb13-report/"}]}}