Pharmacogenetics · De Novo DEN180028
23andMe: Pharmacogenetic reports, eight genes
FDA record DEN180028: De Novo request granted on October 31, 2018 for 23andMe. It is one of the four tests on FDA's own Direct-to-Consumer Tests table.
- FDA device name
- 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
- Applicant (as FDA lists it)
- 23AndMe, Inc.
- FDA decision
- De Novo request granted
- Decision date
- October 31, 2018
- Product code
- QDJ
- Regulation
- 21 CFR 862.3364
FDA database entry · FDA decision summary (PDF) · openFDA record
What the authorization says it may report
This report describes if a person has variants associated with metabolism of some therapeutics, but does not describe if a person will or will not respond to a particular therapeutic, and does not describe the association between detected variants and any specific therapeutic.
The information provided by this report should not be used to start, stop, or change any course of treatment.
Stated limitations
Results should be confirmed in a clinical setting with independent genetic testing before taking any medical action.
This test does not diagnose any health conditions, predict drug response, provide medical advice, or determine whether a medication is indicated for the user.
FDA classifies this test type under 21 CFR 862.3364, which says: “A pharmacogenetic assessment system is a qualitative in vitro molecular diagnostic system intended to detect nucleic acid variants isolated from human specimens for the purpose of assessing the presence of genetic variants that impact the metabolism, exposure, response, risk of adverse events, dosing, or mechanisms of prescription or over-the-counter medications.” (21 CFR 862.3364)
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)
Other pharmacogenetics records
23andMe: CYP2C19 report with drug information
How the body processes some medications (CYP2C19: citalopram, clopidogrel)
23andMe: SLCO1B1 report with drug information
How the body processes some medications (SLCO1B1: simvastatin; CYP2C19: citalopram, clopidogrel)