Test type
Pharmacogenetics tests: what FDA reviews
For people who want to know: how my body may process medications.
What FDA says
FDA reviews before sale
FDA: “Pharmacogenetics tests provide information regarding the role genetics may play in an individual's reaction to drugs.” (U.S. Food and Drug Administration)
FDA's page, last updated December 20, 2019, also says “Currently the FDA has not authorized any DTC pharmacogenetic tests that predict whether an individual is likely to respond to or have adverse reactions from any specific therapeutic drug.” (U.S. Food and Drug Administration)
Two later 510(k) clearances in FDA's database add drug-specific information to particular 23andMe reports. Here is what each FDA file says the reports may state, and the limits it sets.
K193492, Aug 17, 2020 (CYP2C19):
23andMe Personal Genome Service pharmacogenetic reports for CYP2C19 describes if a person has variants associated with metabolism of some therapeutics and provides interpretive drug information regarding the potential effect of the identified metabolizer phenotype on citalopram and clopidogrel therapy.
This report does not determine if a person will or will not respond to a particular therapeutic.
This test does not provide interpretive drug information for the CYP2C19 *3/*17 heterozygous genotype.
K221885, Oct 26, 2022 (SLCO1B1, plus the other reports):
23andMe Personal Genome Service pharmacogenetics report for SLCO1B1 describes if a person has variants associated with the processing of some therapeutics and provides interpretive drug information regarding the potential effect of the identified transport function phenotype on simvastatin therapy.
The 23andMe Personal Genome Service pharmacogenetic reports for CYP2C9, CYP3A5, UGT1A1, DPYD, TPMT and CYP2D6 describe 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.
This test does not determine if a person will or will not respond to a particular therapeutic.
For CYP2C19 only: This test does not provide interpretive drug information for the CYP2C19 *3/*17 genotype or other CYP2C19 genotype combinations where the predicted metabolizer profile cannot be interpreted.
Do not use your results to start, stop or change any course of treatment.
These are the records we reviewed; they don't tell you what any company sells today.
FDA's page on review:
Companies that offer DTC pharmacogenetic tests are required to come to FDA for premarket review and clearance.
FDA records under product code QDJ: three.
23andMe: Pharmacogenetic reports, eight genes
How the body processes some medications (CYP2C19, CYP2C9, CYP3A5, UGT1A1, DPYD, TPMT, SLCO1B1, CYP2D6)
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)
The federal rule
FDA classifies these tests 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 every home DNA result has in common
FDA: “No test is 100% accurate.” (U.S. Food and Drug Administration) MedlinePlus adds that “additional testing through a healthcare provider is usually required before direct-to-consumer test results can be used to diagnose a medical condition or make healthcare decisions.” (MedlinePlus)
Other test types
- Carrier screening: exempt from premarket notification, with conditions (FDA's wording and conditions are on that page)
- Genetic health risk: first test reviewed; later tests exempt, with conditions (FDA's wording and conditions are on that page)
- Cancer predisposition: FDA reviews before sale (FDA's wording and conditions are on that page)
- Ancestry: not reviewed by FDA (FDA's wording and conditions are on that page)
- Wellness and traits: generally not reviewed by FDA (FDA's wording and conditions are on that page)