At-Home DNA Tests

US guide · FDA data as of Sep 28, 2026

What can an at-home DNA test legally tell you?

Some home DNA tests go through FDA review before they're sold. Many don't. This guide lists the thirteen FDA authorizations recorded under the four product codes FDA uses for direct-to-consumer genetic health risk, cancer predisposition, carrier screening and pharmacogenetic tests, as of September 28, 2026. It quotes what each says the test may report, and explains which kinds of tests FDA doesn't review.

"At-home" here means direct-to-consumer. FDA: “In vitro diagnostics (IVDs) that are marketed directly to consumers without the involvement of a health care provider are called direct-to-consumer tests (also referred to as DTC).” (U.S. Food and Drug Administration) A kit you collect at home but that a clinician orders isn't direct-to-consumer, and isn't covered here.

I want to know…

Pick one to see what FDA says about that kind of test and which authorizations exist.

All six answers are below.

Whether I carry a variant I could pass to a child: carrier screening

Exempt from premarket notification, with conditions

FDA: “These tests can be used to determine whether a healthy person carries a genetic variant that could be passed on to their potential future child(ren).” (U.S. Food and Drug Administration)

FDA explains the inheritance pattern these tests are about: “These tests are for disorders where two copies of an abnormal gene variant must be present for the disease or condition to develop, meaning that each parent has one copy of the abnormal variant that could be passed on, giving the child a 25% chance of developing the disease or condition.” (U.S. Food and Drug Administration)

The regulated device type is the autosomal recessive carrier screening gene mutation detection system, defined in 21 CFR 866.5940:

Autosomal recessive carrier screening gene mutation detection system is a qualitative in vitro molecular diagnostic system used for genotyping of clinically relevant variants in genomic DNA isolated from human specimens intended for prescription use or over-the-counter use. The device is intended for autosomal recessive disease carrier screening in adults of reproductive age. The device is not intended for copy number variation, cytogenetic, or biochemical testing.

Its exemption from premarket notification has conditions written into the same regulation:

The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9, except § 866.9(c)(2). Autosomal recessive carrier screening gene mutation detection system must comply with the following special controls:

The excepted limitation, § 866.9(c)(2), covers devices “For use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism;” (21 CFR 866.9) The general limitation in § 866.9 still applies: “The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality.” (21 CFR 866.9)

Exemption from premarket notification is not exemption from FDA's other requirements. FDA's page puts it this way:

Carrier screening tests are exempt from FDA premarket review, but they do need to follow specific requirements that are described in the regulation for this type of test.

FDA records under product code PKB: one.

Carrier screening tests: the full page

My genetic risk for a disease: genetic health risk

First test reviewed; later tests exempt, with conditions

FDA: “GHR tests are intended to provide information on an individual's genetic risk for certain medical diseases or conditions.” (U.S. Food and Drug Administration) “The GHR tests are intended to provide genetic risk information to consumers, but these tests do not determine a person's overall risk of developing a disease or condition.” (U.S. Food and Drug Administration)

The regulation, 21 CFR 866.5950, sets the conditions for that exemption:

The genetic health risk assessment system device, when it has previously received a first-time FDA marketing authorization (e.g., 510(k) clearance) for the genetic health risk assessment system (a “one-time FDA reviewed genetic health risk assessment system”), is exempt from the premarket notification procedures in part 807, subpart E, of this chapter subject to the limitations in § 866.9. The device must comply with the following special controls:

The limitation in § 866.9 restricts any such exemption: “The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality.” (21 CFR 866.9) The special controls include an opt-in step: “When the test reports the risk of a life-threatening or irreversibly debilitating disease or condition for which there are few or no options to prevent, treat, or cure the disease, a user opt-in section must be provided.” (21 CFR 866.5950) They also require the label to say that “other companies offering a genetic risk test may be detecting different genetic variants for the same disease, so the user may get different results using a test from a different company.” (21 CFR 866.5950)

A report offered under this exemption doesn't go through its own premarket notification, so it may not appear in FDA's database under its own number. The name lookup on this site can't tell you whether such a report meets the conditions.

FDA's page summarizes the arrangement:

Companies that offer DTC GHR tests are required to obtain FDA clearance prior to offering their first test. Companies may then offer most additional DTC GHR tests without FDA premarket review, provided they meet specific requirements that are described in the regulation for this type of test and are not for specific higher risk uses.

FDA records under product code PTA: five.

Genetic health risk tests: the full page

My inherited cancer risk: cancer predisposition

FDA reviews before sale

FDA: “These tests provide information about an individual's risk of getting certain types of cancer.” (U.S. Food and Drug Administration)

FDA's database shows four decisions under this product code, listed below. Two concern the same BRCA1/BRCA2 report: a 2018 De Novo grant for three variants and a 2023 510(k) clearance for 44.

FDA's page on review:

These tests are considered moderate to high risk and are required to come to FDA for premarket review and clearance.

FDA records under product code QAZ: four.

Cancer predisposition tests: the full page

How my body may process medications: pharmacogenetics

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.

Pharmacogenetics tests: the full page

Where my ancestors came from: ancestry

Not reviewed by FDA

FDA has no list of ancestry tests to check against. An ancestry kit still collects your DNA, so the privacy questions apply just the same.

FDA's page:

Some tests are used to help individuals explore their genetic ancestry. The FDA does not review these types of tests.

FDA records for this type: none. There is nothing to match a product against.

Ancestry tests: the full page

Fitness, diet, sleep or traits: wellness and traits

Generally not reviewed by FDA

FDA: “In general, direct-to-consumer tests for non-medical, general wellness, or low risk medical purposes are not reviewed by the FDA before they are offered.” (U.S. Food and Drug Administration)

A "wellness" or "trait" label on a product doesn't decide its regulatory status. FDA ties review to the test's purpose and risk: “Direct-to-consumer tests for moderate to high risk medical purposes, which may have a higher impact on medical care, are generally reviewed by the FDA to determine the validity of test claims.” (U.S. Food and Drug Administration)

FDA's page on general wellness tests:

Some tests are offered for purposes the FDA considers general wellness, such as tests that predict athletic ability. The FDA generally does not review low risk general wellness products.

FDA records for this type: none. There is nothing to match a product against.

Wellness and traits tests: the full page

How FDA sorts home DNA tests

“Some direct-to-consumer tests are reviewed by the FDA while others are not.” (U.S. Food and Drug Administration)

Direct-to-consumer tests for moderate to high risk medical purposes, which may have a higher impact on medical care, are generally reviewed by the FDA to determine the validity of test claims.

“In general, direct-to-consumer tests for non-medical, general wellness, or low risk medical purposes are not reviewed by the FDA before they are offered.” (U.S. Food and Drug Administration)

FDA keeps a table of authorized direct-to-consumer tests on its Direct-to-Consumer Tests page. That page says “The direct-to-consumer tests listed below have undergone an evaluation by the FDA for accuracy, reliability, and consumer comprehension.” (U.S. Food and Drug Administration) It was last updated on December 20, 2019, and lists four authorizations. Of the thirteen records on this site, five were decided on or before that date (FDA's table doesn't include K182784, from Jan 18, 2019), and eight were decided after it.

Before you buy one as a gift

The FTC's holiday advice starts with “Take a close look at the company’s privacy promises.” (FTC, archived May 13, 2026) It also warns: “It tells a story not just about you, but also about people you’re related to.” (FTC, archived May 13, 2026)

Use the gift-buyer's privacy checklist, and read what HIPAA and GINA do and don't cover.

Questions people ask

Has FDA authorized 23andMe's tests?

FDA records name 23andMe on nine of the thirteen authorizations on this site, each for specific reports: carrier status for Bloom syndrome, ten genetic health risk reports, BRCA1/BRCA2 selected variants, MUTYH-associated polyposis, HOXB13 prostate cancer, and pharmacogenetic reports. FDA's records use the words "granted" for De Novo requests and "substantially equivalent" for 510(k) clearances. See every record on this site.

Does FDA review ancestry DNA tests?

No. FDA's page says: “Some tests are used to help individuals explore their genetic ancestry. The FDA does not review these types of tests.” (U.S. Food and Drug Administration)

Can an at-home DNA test tell me which medications will work for me?

FDA's Direct-to-Consumer Tests page, last updated in December 2019, 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 clearances add drug-specific information to particular 23andMe reports (citalopram and clopidogrel for CYP2C19, simvastatin for SLCO1B1). The 2022 FDA file still says: “This test does not determine if a person will or will not respond to a particular therapeutic.” and “Do not use your results to start, stop or change any course of treatment.” (FDA 510(k) file, K221885) Read what each report may say.

If my result is negative, am I in the clear?

Not necessarily. FDA says “it is important that consumers understand that a negative result means they still may be at risk for a particular disease or condition.” (U.S. Food and Drug Administration)

Why did two companies give me different results?

FDA says “Not all direct-to-consumer genetic test companies test for the same set of variants, and therefore may provide different results for the same disease or condition.” (U.S. Food and Drug Administration)

Does HIPAA protect my DNA test data?

It depends on who holds the data. The HIPAA rules say “the standards, requirements, and implementation specifications adopted under this subchapter apply to the following entities: (1) A health plan. (2) A health care clearinghouse. (3) A health care provider who transmits any health information in electronic form in connection with a transaction covered by this subchapter.” (45 CFR 160.102) They add: “Where provided, the standards, requirements, and implementation specifications adopted under this subchapter apply to a business associate.” (45 CFR 160.102) Whether a test company is one of these, or a business associate of one, for your test is something FDA records don't say; ask the company. More on HIPAA.

Can my employer or health insurer use my results?

“The Genetic Information Nondiscrimination Act (GINA) of 2008 protects Americans from discrimination based on their genetic information in both health insurance (Title I) and employment (Title II).” (NHGRI) In employment, “Title II of GINA prohibits the use of genetic information in making employment decisions, restricts employers and other entities covered by Title II (employment agencies, labor organizations and joint labor-management training and apprenticeship programs - referred to as "covered entities") from requesting, requiring or purchasing genetic information, and strictly limits the disclosure of genetic information.” (EEOC) GINA has limits: “GINA’s health insurance protections do not cover long-term care insurance, life insurance, or disability insurance” (NHGRI), and “GINA does not apply to employers with fewer than 15 employees.” (NHGRI) It also isn't a general ban on decisions about a disease you already have: the employment title says a covered employer “shall not be considered to be in violation of this title based on the use, acquisition, or disclosure of medical information that is not genetic information about a manifested disease, disorder, or pathological condition of an employee or member, including a manifested disease, disorder, or pathological condition that has or may have a genetic basis.” (GINA Title II, Sec. 210) More on GINA.

What should I check before giving a DNA kit as a holiday gift?

The FTC's holiday advice starts with “Take a close look at the company’s privacy promises.” (FTC, archived May 13, 2026) It asks: “Do they share users’ information with other companies?” (FTC, archived May 13, 2026) and “Can you delete your information if you want to?” (FTC, archived May 13, 2026) See the gift-buyer checklist.

If I can't find a test here, does that mean it's illegal?

No. Some genetic tests can be sold without their own premarket submission if they meet conditions in FDA's rules. For autosomal recessive carrier screening, FDA says “Carrier screening tests are exempt from FDA premarket review, but they do need to follow specific requirements that are described in the regulation for this type of test.” (U.S. Food and Drug Administration) For genetic health risk tests, “Companies that offer DTC GHR tests are required to obtain FDA clearance prior to offering their first test. Companies may then offer most additional DTC GHR tests without FDA premarket review, provided they meet specific requirements that are described in the regulation for this type of test and are not for specific higher risk uses.” (U.S. Food and Drug Administration) FDA's page says it does not review ancestry tests and generally does not review low-risk general wellness products.

Every quote on this site links to its source. Records come from FDA's 510(k) and De Novo databases via openFDA (data last updated September 28, 2026); quotes were rechecked on October 12, 2026. How we built this.