At-Home DNA Tests

Cancer predisposition · 510(k) K182784

23andMe: MUTYH-associated polyposis

FDA record K182784: 510(k) cleared on January 18, 2019 for 23andMe. It isn't on FDA's Direct-to-Consumer Tests table (last updated December 20, 2019), though it was decided before that update; it appears in FDA's device database.

FDA recordK182784
FDA device name
MUTYH-Associated Polyposis (MAP)
Applicant (as FDA lists it)
23AndMe, Inc.
FDA decision
Substantially equivalent (cleared)
Decision date
January 18, 2019 (received Oct 1, 2018)
Product code
QAZ
Regulation
21 CFR 866.6090

FDA database entry · FDA 510(k) file (PDF) · openFDA record

What the authorization says it may report

The 23andMe PGS Genetic Health Risk Report for MUTYH-Associated Polyposis is indicated for reporting of the Y179C and the G396D variants in the MUTYH gene. The report describes if a person is at increased risk of developing colorectal cancer.

The two variants included in this report are most common and best studied in people of Northern European descent and may not represent the majority of the MUTYH variants found in people of other ethnicities.

Genes or markers named: MUTYH

Stated limitations

This test is not intended to diagnose a disease, determine medical treatment or other medical intervention, or tell the user anything about their current state of health.

the absence of a variant tested does not rule out the presence of other variants that may be cancer-related.

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

About cancer predisposition tests · All FDA records