{"entity":{"id":"23andme-mutyh-report","kind":"drug","name":"23andMe Genetic Health Risk Report for MUTYH-Associated Polyposis","aka":[],"tldr":"A saliva test sold directly to the public that looks for two common changes in the MUTYH gene, which in two copies cause an inherited bowel polyp condition. A negative result does not rule out other MUTYH changes.","summary":"Cleared by the FDA on 18 January 2019 (510(k) K182784) under the cancer predisposition risk assessment device type (product code QAZ). The indications for use: reporting of the Y179C and G396D variants in MUTYH, describing whether a person is at increased risk of colorectal cancer; the two variants 'are most common and best studied in people of Northern European descent and may not represent the majority of the MUTYH variants found in people of other ethnicities'. The report does not describe overall cancer risk and is not to be used to determine treatment.","status":"approved","asOf":"2026-11-04","links":[{"label":"FDA 510(k) K182784","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K182784"}],"tags":["test","hereditary"],"related":[],"cancers":[],"sections":[],"technologies":["germline-testing"],"targets":["mutyh"],"drugs":[],"companies":["23andme"],"institutions":[],"pathways":[],"terms":["mutyh-associated-polyposis","hereditary-cancer-syndromes"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"23andMe PGS Genetic Health Risk Report for MUTYH-Associated Polyposis","modality":"Direct-to-consumer saliva genetic test (genotyping) for two MUTYH variants","mechanism":"Qualitative genotyping of DNA from saliva for the MUTYH variants Y179C and G396D.","approvals":[{"region":"US","year":2019,"indication":"Over-the-counter report of the MUTYH Y179C and G396D variants (510(k) K182784)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2019-01-18","type":"approval","region":"US","note":"510(k) K182784 cleared, product code QAZ.","source":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K182784"}]},"route":"/drugs/23andme-mutyh-report/","neighbours":{"technology":[{"id":"germline-testing","kind":"technology","name":"Germline (hereditary) testing","route":"/technologies/germline-testing/"}],"target":[{"id":"mutyh","kind":"target","name":"MUTYH","route":"/targets/mutyh/"}],"company":[{"id":"23andme","kind":"company","name":"23andMe","route":"/companies/23andme/"}],"term":[{"id":"hereditary-cancer-syndromes","kind":"term","name":"Hereditary cancer syndromes","route":"/terms/hereditary-cancer-syndromes/"},{"id":"mutyh-associated-polyposis","kind":"term","name":"MUTYH-associated polyposis","route":"/terms/mutyh-associated-polyposis/"}]}}