{"entity":{"id":"23andme-brca-report","kind":"drug","name":"23andMe Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)","aka":[],"tldr":"A saliva test sold directly to the public that looks for a short list of known BRCA1 and BRCA2 changes. A negative result does not rule out an inherited BRCA change, because most such changes are not on the list.","summary":"De Novo DEN170046, granted by the FDA on 6 March 2018, created the 'cancer predisposition risk assessment system' device type (21 CFR 866.6090, product code QAZ) for over-the-counter use in adults. As first authorised it reported three variants, 185delAG and 5382insC in BRCA1 and 6174delT in BRCA2, which the labelling says 'are most common in people of Ashkenazi Jewish descent and do not represent the majority of the BRCA1/BRCA2 variants in the general population'. A 510(k) clearance on 31 August 2023 (K223597) extended the report to 44 BRCA1 and BRCA2 variants. The labelling states the test does not diagnose cancer, should not be used to make medical decisions or determine treatment, and that results should be confirmed in a clinical setting before any medical action.","status":"approved","asOf":"2026-11-04","links":[{"label":"FDA De Novo DEN170046","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN170046"},{"label":"FDA decision summary DEN170046 (PDF)","url":"https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN170046.pdf"},{"label":"FDA 510(k) K223597","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223597"}],"tags":["test","hereditary"],"related":[],"cancers":[],"sections":[],"technologies":["germline-testing"],"targets":["brca"],"drugs":[],"companies":["23andme"],"institutions":[],"pathways":[],"terms":["gbrca-mutation","hereditary-cancer-syndromes"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["What a result means: a variant found should be confirmed by a clinical test and discussed with a genetics service; no variant found does not mean no inherited risk, and anyone with a family history of breast, ovarian, pancreatic or prostate cancer should still be assessed for full BRCA testing."],"brand":"23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)","modality":"Direct-to-consumer saliva genetic test (genotyping) for selected BRCA1/BRCA2 variants","mechanism":"Qualitative genotyping of DNA from saliva for a fixed list of BRCA1 and BRCA2 variants; it does not sequence the genes, so variants not on the list are not detected.","approvals":[{"region":"US","year":2018,"indication":"Over-the-counter report of three BRCA1/BRCA2 variants for adults (De Novo DEN170046)"},{"region":"US","year":2023,"indication":"Report expanded to 44 BRCA1 and BRCA2 variants (510(k) K223597)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2018-03-06","type":"approval","region":"US","note":"De Novo DEN170046 granted; new regulation 21 CFR 866.6090, product code QAZ.","source":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN170046"},{"date":"2023-08-31","type":"label-change","region":"US","note":"510(k) K223597 cleared, extending the report to 44 variants.","source":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223597"}]},"route":"/drugs/23andme-brca-report/","neighbours":{"technology":[{"id":"germline-testing","kind":"technology","name":"Germline (hereditary) testing","route":"/technologies/germline-testing/"}],"target":[{"id":"brca","kind":"target","name":"BRCA1 / BRCA2 (HRD)","route":"/targets/brca/"}],"company":[{"id":"23andme","kind":"company","name":"23andMe","route":"/companies/23andme/"}],"term":[{"id":"gbrca-mutation","kind":"term","name":"Germline BRCA mutation (gBRCA)","route":"/terms/gbrca-mutation/"},{"id":"hereditary-cancer-syndromes","kind":"term","name":"Hereditary cancer syndromes","route":"/terms/hereditary-cancer-syndromes/"}]}}