Direct-to-Consumer Genetic Tests

Start here: what a result can and cannot do

A direct-to-consumer (DTC) genetic test is one you order and send in yourself, usually a saliva sample, without a health care provider involved. [1] A result is a piece of information, not a diagnosis. The FDA says results should not be the sole basis of a medical decision and should not be used to decide on treatment. [1] Please do not start, stop or change a medicine or a screening plan because of a DTC report. Talk with a clinician or genetic counselor first. See talking with a health professional.

This page uses evidence labels such as approved medicine, promising but limited and marketing claim, explained in how we label evidence. A test and a technology are different things: one company's authorized test does not make other DNA tests valid.

Kinds of DTC genetic tests

MedlinePlus describes carrier and disease-risk tests, pharmacogenomic tests, trait tests, lifestyle tests and ancestry tests. [2] Lifestyle tests predict things like nutrition, fitness or sleep, and the company may then recommend diets, supplements or other products. MedlinePlus notes that the link between a gene variant and a complex trait such as weight, athletic performance or sleep is complicated. [2] See DNA-based diets for what trials show.

How the FDA treats DTC tests (United States, read 2026-10-22)

The FDA regulates these tests as medical devices, and requirements depend on risk. [1] In general, tests for non-medical, general wellness or low-risk purposes are not reviewed before they are sold, while tests for moderate to high-risk medical purposes are generally reviewed. [1] Ancestry tests are not reviewed by the FDA. [1] When it does review a test, the FDA looks at analytical validity (does it measure what it claims), clinical validity (does the measurement predict a health state) and the claims made. [1]

Pathways differ by test type. Carrier screening tests are exempt from premarket review but must follow set requirements. Genetic health risk tests need clearance for a company's first test, after which most further ones can be offered without premarket review if they meet set requirements. Pharmacogenetic and cancer predisposition tests must come to the FDA for review. [1] Laboratory developed tests, made and run in a single laboratory and offered only when a provider prescribes them, are generally not FDA-reviewed as a matter of policy. [1] The FDA's rule on these laboratory tests was vacated by a federal court on March 31, 2025, and the agency issued a rule restoring the earlier text on September 19, 2025. [3]

Tests the FDA lists as authorized (exact tests, as read)

The FDA page lists the following DTC tests as having marketing authorization. The page shows "Content current as of: 12/20/2019", so authorizations after that date may exist and were not checked. [1]

[1] The FDA also states that, at the time of that page, it had not authorized any DTC pharmacogenetic test that predicts response or adverse reactions to a specific medicine. [1]

Accuracy, false results and confirmation

The FDA says no test is 100% accurate and that different companies test different variants, so results can differ. [1] A negative result does not mean you will not develop a condition. [1] In a UK Biobank evaluation of consumer-style SNP chips, accuracy exceeded 99% for common variants, but only 16% of 4,757 heterozygous genotype calls for very rare variants were confirmed by sequencing. [4] A US laboratory that reviewed 49 samples sent for confirmation found that 40% of variants reported in DTC raw data were false positives. [5] MedlinePlus says DTC results typically need confirmation by testing ordered through a health care provider before they can be considered diagnostic. [6] More in genetic test false positives and clinical confirmation.

Privacy, family and insurance

Relatives share DNA, so your result can have implications for them. [6] MedlinePlus lists risks including data being sold, shared or breached, transfer of data if a company is sold or closes, and disclosure to law enforcement. [7] In the United States, GINA bars health insurers and employers from using genetic information in the ways it covers, but it does not apply to employers with fewer than 15 employees and does not cover life, disability or long-term care insurance, though some state laws add protection. [6][8] See genetic privacy and incidental findings.

Questions worth asking before you order

• Is the test FDA-reviewed, and for which exact report? [6]
• Does the laboratory hold CLIA, CAP or AABB certification? [6]
• How many variants are tested for each condition, and is genetic counseling included? [6]
• Can you delete your data and opt out of sharing or research use? [6]