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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.
De Novo DEN170046, granted by the FDA on 6 March 2018, created the 'cancer predisposition risk assessment system' device type (21 CFR 866.6090, product code QAZ) for over-the-counter use in adults. As first authorised it reported three variants, 185delAG and 5382insC in BRCA1 and 6174delT in BRCA2, which the labelling says 'are most common in people of Ashkenazi Jewish descent and do not represent the majority of the BRCA1/BRCA2 variants in the general population'. A 510(k) clearance on 31 August 2023 (K223597) extended the report to 44 BRCA1 and BRCA2 variants. The labelling states the test does not diagnose cancer, should not be used to make medical decisions or determine treatment, and that results should be confirmed in a clinical setting before any medical action.
Qualitative genotyping of DNA from saliva for a fixed list of BRCA1 and BRCA2 variants; it does not sequence the genes, so variants not on the list are not detected. Connects to BRCA1 / BRCA2 (HRD).
De Novo DEN170046 granted; new regulation 21 CFR 866.6090, product code QAZ. source
510(k) K223597 cleared, extending the report to 44 variants. source
| Region | Year | Indication |
|---|---|---|
| US | 2018 | Over-the-counter report of three BRCA1/BRCA2 variants for adults (De Novo DEN170046) |
| US | 2023 | Report expanded to 44 BRCA1 and BRCA2 variants (510(k) K223597) |
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Query for this drug: (TITLE:"23andMe Genetic Health Risk Report for BRCA1/BRCA2" OR ABSTRACT:"23andMe Genetic Health Risk Report for BRCA1/BRCA2" OR TITLE:"Selected Variants" OR ABSTRACT:"Selected Variants" OR TITLE:"23andMe PGS Genetic Health Risk Report for BRCA1" OR ABSTRACT:"23andMe PGS Genetic Health Risk Report for BRCA1" OR TITLE:"BRCA2" OR ABSTRACT:"BRCA2") 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 Health Risk Report for BRCA1/BRCA2 (Selected Variants), 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, BRCA1 / BRCA2 (HRD), Germline (hereditary) testing and the tags test, hereditary.
Shares Germline BRCA mutation (gBRCA), Hereditary cancer syndromes, BRCA1 / BRCA2 (HRD), Germline (hereditary) testing and the tags test, hereditary.
Shares Hereditary cancer syndromes, BRCA1 / BRCA2 (HRD), Germline (hereditary) testing and the tags test, hereditary.
Shares Hereditary cancer syndromes, BRCA1 / BRCA2 (HRD), Germline (hereditary) testing and the tags test, hereditary.
Shares Hereditary cancer syndromes, BRCA1 / BRCA2 (HRD), Germline (hereditary) testing and the tags test, hereditary.
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