At-Home DNA Tests

Cancer predisposition · De Novo DEN170046

23andMe: BRCA1/BRCA2, three selected variants

FDA record DEN170046: De Novo request granted on March 6, 2018 for 23andMe. It is one of the four tests on FDA's own Direct-to-Consumer Tests table.

FDA recordDEN170046
FDA device name
23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
Applicant (as FDA lists it)
23AndMe, Inc.
FDA decision
De Novo request granted
Decision date
March 6, 2018 (received Sep 5, 2017)
Product code
QAZ
Regulation
21 CFR 866.6090

FDA database entry · FDA decision summary (PDF) · openFDA record

What the authorization says it may report

The 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) is indicated for reporting of the 185delAG and 5382insC variants in the BRCA1 gene and the 6174delT variant in the BRCA2 gene. The report describes if a woman is at increased risk of developing breast and ovarian cancer, and if a man is at increased risk of developing breast cancer or may be at increased risk of developing prostate cancer.

The three variants included in this report are most common in people of Ashkenazi Jewish descent and do not represent the majority of the BRCA1/BRCA2 variants in the general population.

Genes or markers named: BRCA1, BRCA2

Stated limitations

There are more than 1,000 different BRCA1/BRCA2 variants known to be associated with increased risk of developing cancer.

Results should be confirmed in a clinical setting before taking any medical action.

FDA classifies this test type under 21 CFR 866.6090, which says: “This assessment system is for over-the-counter use. This device does not determine the person's overall risk of developing any types of cancer.” (21 CFR 866.6090)

What this record doesn't tell you

An FDA record says what a test was authorized to report on the decision date. It doesn't say whether the product is still sold, what it costs, or which version a kit in a store uses. Check the company's own label and report for the current claims.

FDA's general advice on direct-to-consumer tests: “Do not make any dietary or health-related decisions without first discussing your test results with your health care provider.” (U.S. Food and Drug Administration) On disease-risk results: “Remember that a positive result from a test does not mean that you will develop that disease or condition.” (U.S. Food and Drug Administration)

Other cancer predisposition records

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