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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.
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.
Qualitative genotyping of DNA from saliva for the HOXB13 G84E variant. Connects to HOXB13.
510(k) K211499 cleared, product code QAZ. source
| Region | Year | Indication |
|---|---|---|
| US | 2022 | Over-the-counter report of the HOXB13 G84E variant (510(k) K211499) |
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Query for this drug: (TITLE:"23andMe Genetic Risk Report for Hereditary Prostate Cancer" OR ABSTRACT:"23andMe Genetic Risk Report for Hereditary Prostate Cancer" OR TITLE:"HOXB13-Related" OR ABSTRACT:"HOXB13-Related" OR TITLE:"23andMe PGS Genetic Health Risk Report for Hereditary Prostate Cancer" OR ABSTRACT:"23andMe PGS Genetic Health Risk Report for Hereditary Prostate Cancer") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about 23andMe Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related), not a curated reading list.
Shares 23andMe, Hereditary cancer syndromes, Germline (hereditary) testing and the tags test, hereditary.
Shares 23andMe, Hereditary cancer syndromes, Germline (hereditary) testing and the tags test, hereditary.
Shares Hereditary cancer syndromes, Germline (hereditary) testing and the tags test, hereditary.
Shares Hereditary cancer syndromes, Germline (hereditary) testing and the tags test, hereditary.
Shares Hereditary cancer syndromes, Germline (hereditary) testing and the tags test, hereditary.
Shares Hereditary cancer syndromes, Germline (hereditary) testing and the tags test, hereditary.
Shares Hereditary cancer syndromes, Germline (hereditary) testing and the tags test, hereditary.
Shares Hereditary cancer syndromes, Germline (hereditary) testing and the tags test, hereditary.
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