Loading
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.
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).
A saliva test sold directly to the public that looks for a short list of known BRCA1 and BRCA2 changes. A negative result does not rule out an inherited BRCA change, because most such changes are not on the list.
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.
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.
Shares 23andMe Genetic Health Risk Report for MUTYH-Associated Polyposis, Hereditary cancer syndromes, Germline (hereditary) testing.
Shares Hereditary cancer syndromes, Germline (hereditary) testing.
Shares Hereditary cancer syndromes, Germline (hereditary) testing.
Shares Hereditary cancer syndromes, Germline (hereditary) testing.
Shares Hereditary cancer syndromes, Germline (hereditary) testing.
Shares Hereditary cancer syndromes, Germline (hereditary) testing.
Shares Hereditary cancer syndromes, Germline (hereditary) testing.
Shares Hereditary cancer syndromes, Germline (hereditary) testing.
Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.
A source that has moved or gone is reported by the weekly link check. /audit/