# 23andMe Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)

Source: https://onco.cc/drugs/23andme-hoxb13-report/  
OnCo record `23andme-hoxb13-report` (Test). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Test
- Status: approved
- Last checked: 2026-11-04
- Tags: test; hereditary
- 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: US 2022: Over-the-counter report of the HOXB13 G84E variant (510(k) K211499)

## Sources

- FDA 510(k) K211499: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211499

## Connected records

- technologies: [Germline (hereditary) testing](https://onco.cc/technologies/germline-testing/)
- targets: [HOXB13](https://onco.cc/targets/hoxb13/)
- companies: [23andMe](https://onco.cc/companies/23andme/)
- terms: [Hereditary cancer syndromes](https://onco.cc/terms/hereditary-cancer-syndromes/)

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JSON: https://onco.cc/api/v1/entities/23andme-hoxb13-report.json