# 23andMe

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

## TL;DR

23andMe sells a saliva-based genetic test directly to consumers, and three of its cancer risk reports (BRCA1 and BRCA2, MUTYH, HOXB13) are authorised by the US regulator.

## Summary

The Personal Genome Service genotypes saliva DNA and reports selected variants. FDA records name 23andMe of Mountain View, California, as the requester of De Novo DEN170046 (BRCA1/BRCA2 selected variants, 2018), which created the cancer predisposition risk assessment device type (21 CFR 866.6090, product code QAZ), and of 510(k) clearances K182784 (MUTYH-associated polyposis, 2019), K211499 (HOXB13 hereditary prostate cancer, 2022) and K223597 (BRCA1/BRCA2 expanded to 44 variants, 2023).

## Fields

- Kind: Company
- Last checked: 2026-11-04
- Also known as: 23andMe, Inc.; 23AndMe; 23andMe Personal Genome Service
- Tags: gap-fill
- HQ: Mountain View, California
- Type: diagnostics
- Website: https://www.23andme.com/

## Notes

- Corporate events after 2023 (ownership, bankruptcy proceedings) were not read in this round and are not recorded.

## Sources

- 23andMe: https://www.23andme.com/
- FDA De Novo DEN170046: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN170046
- FDA 510(k) K223597: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223597

## Connected records

- fronts: [Diagnostics & Biomarkers](https://onco.cc/fronts/diagnostics/), [Prevention & Risk](https://onco.cc/fronts/prevention/)
- technologies: [Germline (hereditary) testing](https://onco.cc/technologies/germline-testing/)
- terms: [Hereditary cancer syndromes](https://onco.cc/terms/hereditary-cancer-syndromes/)
- drugs: [23andMe Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)](https://onco.cc/drugs/23andme-brca-report/), [23andMe Genetic Health Risk Report for MUTYH-Associated Polyposis](https://onco.cc/drugs/23andme-mutyh-report/), [23andMe Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)](https://onco.cc/drugs/23andme-hoxb13-report/)

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