About this guide

A facts-only reference to what US regulators have said about direct-to-consumer genetic tests. It doesn't recommend tests, rank companies or give medical advice.

How the list is built

We ask openFDA for every 510(k) and De Novo record under the four product codes FDA uses for direct-to-consumer genetic test types: PTA (genetic health risk), QAZ (cancer predisposition risk), PKB (autosomal recessive carrier screening) and QDJ (direct-to-consumer pharmacogenetic assessment). On October 12, 2026 the queries returned PTA 5, QAZ 4, PKB 1, QDJ 3: thirteen records in all. openFDA's data was last updated September 28, 2026. The list covers those four codes only; it isn't a census of every genetic test you can collect at home. For each record we read FDA's decision document and quote, word for word, what it says the test may report and its stated limitations.

A script refetches every source and checks that each quote still appears verbatim, that each record's number, decision date and product code match FDA's database page, and that its regulation matches FDA's classification record. The site won't build if any check fails. Last check: October 12, 2026, 50 pages, 142 quotes.

openFDA returns two device names with Windows-1252 characters as control codes (an apostrophe and a trademark sign). We map them back and keep the original strings in the dataset as device_name_raw.

The dataset

athomednatests-2026.json is the frozen snapshot this site is built from: records, quotes, source URLs, query URLs and totals.

SHA-256: 117f379a022314410b26c42acc38705b7a2819bf6e831622e94d5e9edc1ede01

Queries: PTA, QAZ, PKB, QDJ (live results may differ from the snapshot).

What the labels mean

• De Novo request granted and 510(k) cleared are FDA's decisions in these records. FDA's DTC page calls them marketing authorizations.
• FDA reviews before sale, First test reviewed; later tests exempt, with conditions, Exempt from premarket notification, with conditions, Not reviewed by FDA and Generally not reviewed by FDA summarize what FDA's Direct-to-Consumer Tests page says about each test type. Each label is shown with FDA's supporting quote beside it, or links to the test-type page where that quote and the regulation's conditions appear.
• We couldn't match this in the name lookup means only that none of our thirteen records names it. It isn't a statement that a product is unlawful.

What we left out

• Autosomal recessive carrier screening reports other than Bloom syndrome, and a company's later genetic health risk reports. 21 CFR 866.5940 and 866.5950 exempt qualifying tests from premarket notification, subject to special controls and the limitations in 21 CFR 866.9, so such reports may have no FDA record of their own to quote.
• Ancestry tests, which FDA's page says it does not review, and low-risk general wellness tests, which it says it generally does not review. A "wellness" label on a product doesn't decide its regulatory status.
• Tests ordered by a doctor, including kits collected at home, and laboratory developed tests.
• Prices, whether a product is still sold, and any accuracy claim beyond FDA's own words.

Sources

• U.S. Food and Drug Administration: Direct-to-Consumer Tests
• eCFR (Office of the Federal Register): 21 CFR 866.5950 Genetic health risk assessment system
• eCFR (Office of the Federal Register): 21 CFR 866.5940 Autosomal recessive carrier screening gene mutation detection system
• eCFR (Office of the Federal Register): 21 CFR 862.3364 Pharmacogenetic assessment system
• eCFR (Office of the Federal Register): 21 CFR 866.6090 Cancer predisposition risk assessment system
• National Human Genome Research Institute (NIH): Privacy in Genomics
• National Human Genome Research Institute (NIH): Genetic Discrimination
• U.S. Equal Employment Opportunity Commission: Genetic Information Discrimination
• MedlinePlus Genetics (National Library of Medicine): What is direct-to-consumer genetic testing?
• MedlinePlus Genetics (National Library of Medicine): What are the pros and cons of direct-to-consumer genetic testing?
• Federal Trade Commission: If DNA test kits are on your holiday shopping list (Consumer Alert, December 19, 2023) (Internet Archive copy, May 13, 2026; original)
• Federal Trade Commission: Keep people’s sensitive DNA information private (Consumer Alert, June 16, 2023) (Internet Archive copy, Jun 16, 2026; original)
• Federal Trade Commission: FTC Says Genetic Testing Company 1Health Failed to Protect Privacy and Security of DNA Data (press release, June 16, 2023) (Internet Archive copy, Sep 30, 2026; original)
• Federal Trade Commission: FTC Chairman Issues Letter on 23andMe Bankruptcy Impact to Consumers (press release, March 31, 2025) (Internet Archive copy, Jun 22, 2026; original)
• eCFR (Office of the Federal Register): 21 CFR 866.9 Limitations of exemptions from section 510(k)
• eCFR (Office of the Federal Register): 45 CFR 160.102 Applicability (HIPAA rules)
• eCFR (Office of the Federal Register): 45 CFR 160.103 Definitions (HIPAA rules)
• U.S. Equal Employment Opportunity Commission: Genetic Information Nondiscrimination Act of 2008 (statute text, Title II)
• HHS Office of Inspector General: Fraud Alert: Genetic Testing Scam
• National Society of Genetic Counselors: Find a Genetic Counselor
• FDA decision documents and database entries for each record, linked from its page.

Sources that refuse automated requests: ftc.gov and consumer.ftc.gov (we quote dated Internet Archive copies and say so beside each quote) and hhs.gov's HIPAA pages (we quote the regulation on eCFR and NIH instead). We don't work around blocks.

Who we are

Published by North Coast AI LLC. Built with AI assistance and reviewed by Bill Burkey. We are not affiliated with the FDA, the FTC, any government agency or any test company, and no company paid to be listed.

Ads and analytics

This site shows Google AdSense ads and uses Google Analytics to count visits. Advertisers have no say in what's listed. There are no affiliate links. The finder only changes the page address after the # sign. A name-lookup search can appear in the page address (for example /tests/?q=brca), where it may be recorded by our server logs and Google Analytics. See the privacy policy.

Corrections

If a quote or record is wrong or out of date, tell us through North Coast AI and include the source link. We fix errors against the official source, not against company marketing.