{"entity":{"id":"23andme-hoxb13-report","kind":"drug","name":"23andMe Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)","aka":[],"tldr":"A saliva test sold directly to the public that looks for one change in the HOXB13 gene, which raises a man's risk of prostate cancer. A negative result does not rule out other inherited prostate cancer risk.","summary":"Cleared by the FDA on 6 January 2022 (510(k) K211499) under the cancer predisposition risk assessment device type (product code QAZ). The indications for use: reporting whether a person has the G84E variant in HOXB13 and whether a male is at increased risk of prostate cancer; the variant is most common in people of European descent. The report does not describe overall cancer risk and is not a substitute for recommended screening.","status":"approved","asOf":"2026-11-04","links":[{"label":"FDA 510(k) K211499","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211499"}],"tags":["test","hereditary"],"related":[],"cancers":[],"sections":[],"technologies":["germline-testing"],"targets":["hoxb13"],"drugs":[],"companies":["23andme"],"institutions":[],"pathways":[],"terms":["hereditary-cancer-syndromes"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"23andMe PGS Genetic Health Risk Report for Hereditary Prostate Cancer (HOXB13-Related)","modality":"Direct-to-consumer saliva genetic test (genotyping) for the HOXB13 G84E variant","mechanism":"Qualitative genotyping of DNA from saliva for the HOXB13 G84E variant.","approvals":[{"region":"US","year":2022,"indication":"Over-the-counter report of the HOXB13 G84E variant (510(k) K211499)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2022-01-06","type":"approval","region":"US","note":"510(k) K211499 cleared, product code QAZ.","source":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211499"}]},"route":"/drugs/23andme-hoxb13-report/","neighbours":{"technology":[{"id":"germline-testing","kind":"technology","name":"Germline (hereditary) testing","route":"/technologies/germline-testing/"}],"target":[{"id":"hoxb13","kind":"target","name":"HOXB13","route":"/targets/hoxb13/"}],"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/"}]}}