Genetic testing marketing: claims, privacy and consent rules to know

Genetic testing is sold in several ways: kits bought online, panels ordered through a clinic, carrier screening offered by fertility and prenatal practices, and pharmacogenetic or hereditary risk tests ordered by specialists. Whatever the model, the people reading your pages are deciding whether to hand over a sample of their DNA, which they cannot change and which also says something about their relatives.

That makes genetic testing marketing a trust exercise with two parts: describe accurately what a test can tell someone, and keep every promise you make about their data. This guide covers both, using FDA, FTC and federal privacy sources, then lists marketing ideas that work inside them.

Know which kind of test you are selling

FDA’s page on direct-to-consumer tests explains that not every test gets the same review. It says tests for general wellness or low risk medical purposes are not reviewed by FDA before they are offered, while direct-to-consumer tests for moderate to high risk medical purposes are generally reviewed to determine the validity of test claims. It adds that FDA does not review ancestry tests.

When FDA does review a test, the page says it looks at whether the test accurately and reliably measures what it claims to measure (analytical validity), whether the measurement predicts a state of health (clinical validity), and what the company says about the test and how well it works. Your marketing should match the review status of each test: never imply FDA review of a wellness or ancestry test, and when a test does have FDA marketing authorization, describe it in the exact terms of that authorization.

Say what a result can and cannot show

FDA’s page makes several points that belong on every genetic test page. It says direct-to-consumer tests have varying levels of evidence behind their claims, that there can be disagreement in the clinical community about the role different genetic variants play in disease, and that not all companies test for the same set of variants, so different tests may give different results for the same condition. It suggests consumers consider discussing results with a genetic counselor or other health care provider.

Section 5 of the FTC Act, 15 U.S.C. 45, prohibits deceptive acts or practices, and the FTC Health Products Compliance Guidance says health benefit claims, express or implied, require competent and reliable scientific evidence. In genetic testing, the risky lines are the ones that turn a probability into a verdict or a plan: know your future, find out if you will get cancer, a diet built for your DNA, or a negative result presented as reassurance. Write instead what the test looks at, what a positive and a negative result do and do not mean, and when to talk to a clinician or genetic counselor.

• Name the type of test and what it examines, in plain words, and link to a page explaining its limits.
• Do not present a negative or low risk result as a clean bill of health.
• Keep wellness, ancestry and medical tests on separate pages, with separate claims.
• If you offer genetic counseling, say who provides it and whether it is included in the price.

Pharmacogenetic tests, which look at genes linked to how certain medicines are processed, raise their own claim, coverage and referral questions. Our pharmacogenomic testing marketing guide covers them, including why results pages should tell patients not to change a medicine without their prescriber.

Privacy promises are claims too

The FTC treats what you say about data the same way it treats what you say about the test. In September 2023 it finalized an order with 1Health.io, formerly Vitagene, a genetic testing company. According to the FTC, the company left sensitive genetic and health data in publicly accessible data storage despite its security promises, did not destroy DNA samples as it had said it would, falsely told consumers they could delete their data, and retroactively expanded its privacy policy in 2020 to allow sharing with more third parties without consent. The order requires affirmative express consent before sharing health data with third parties, destruction of retained DNA samples, and an information security program.

The lesson for marketing teams is simple: every line about security, deletion, sample storage and sharing must be true today and stay true. Check with your lab and engineers before writing phrases such as bank-level security, we never share your data or delete anytime. If your practices change, do not apply a broader policy to data you already hold without fresh consent.

Which privacy rules apply

Under 45 CFR 160.103, health information includes genetic information. If your service is a HIPAA covered entity, for example a clinic or lab that bills health plans electronically, using a customer’s information in marketing generally requires their written authorization under 45 CFR 164.508; see our guide to HIPAA marketing rules.

Many direct-to-consumer genetic services are not HIPAA covered entities. For apps and services that hold consumers’ health records outside HIPAA, the FTC Health Breach Notification Rule, 16 CFR Part 318, may apply; our guide to the FTC Health Breach Notification Rule explains who it covers. State genetic privacy laws differ, so check the law in each state you sell into.

Describe GINA accurately

Customers often worry that a test result could hurt their job or insurance, and marketing copy is tempted to wave that away. Be precise. The EEOC says Title II of the Genetic Information Nondiscrimination Act makes it illegal to discriminate against employees or applicants because of genetic information, and 42 U.S.C. 2000ff-1 sets out that employment rule. The National Human Genome Research Institute notes that GINA does not apply to employers with fewer than 15 employees, and that its health insurance protections do not cover long-term care, life or disability insurance, though state laws can add protections.

So avoid lines such as federal law protects you from genetic discrimination with no limits. If you mention GINA, say what it covers and what it does not, and link to the government source.

Tracking on test pages

A page view for a hereditary cancer panel, a carrier screen or a pharmacogenetic test can reveal something sensitive about the visitor. Keep test names, cart contents, order details and results out of advertising platforms, and review what your tags collect on product, checkout and results pages. Our guide to tracking pixels on practice websites covers the issues, and the 1Health.io order shows the FTC expects consent before health data is shared with third parties.

Customer stories and reviews

A story about a test that found a hidden risk is powerful and easy to overstate. Under the Endorsement Guides, 16 CFR 255.2(b), an ad that relates one customer’s experience on a key point is likely to be read as typical, so without substantiation that it is representative, it should clearly disclose the generally expected results. 16 CFR Part 465 prohibits fake reviews and incentives conditioned on positive ones. Never publish a customer’s genetic result or a family history detail without written permission, and with written authorization where HIPAA applies.

Genetic testing marketing ideas that work inside the rules

1. One page per test. What it examines, who might consider it, how the sample is collected, turnaround, what results can and cannot show, its FDA review status and who to talk to about results.
2. A plain data page. Where samples and data are stored, for how long, who can see them, what is shared and with whom, and how deletion and sample destruction work, written to match what actually happens.
3. A consent step you can prove. Separate, clear choices for research use and any sharing, recorded with the date and the wording shown.
4. Genetic counseling information. Who provides it, how to book, and whether it is included. Our medical website design page explains how we build pages like these.
5. Search pages for real questions. Topics such as what carrier screening is or what a variant of uncertain significance means, written with a genetics professional; see our healthcare SEO page.
6. Ads that match the page. Ad text and landing pages that make the same claims as the test page, with the same limits.

If you also sell other lab tests directly to consumers, see our guide to direct-to-consumer lab testing marketing. For primary care invitations to a family history review before any counseling or testing, see our guide to hereditary cancer risk assessment outreach.

Sources

• FDA: Direct-to-Consumer Tests
• FTC: FTC Finalizes Order with 1Health.io (September 7, 2023)
• FTC: Health Products Compliance Guidance (December 2022)
• 15 U.S.C. 45: Unfair methods of competition and unfair or deceptive acts or practices
• 16 CFR Part 318: Health Breach Notification Rule
• 16 CFR 255.2: Consumer endorsements
• 16 CFR Part 465: Use of consumer reviews and testimonials
• 45 CFR 160.103: Definitions (health information)
• 45 CFR 164.508: Uses and disclosures for which an authorization is required
• 42 U.S.C. 2000ff-1: Employer practices (GINA Title II)
• EEOC: Genetic Information Discrimination
• National Human Genome Research Institute: Genetic Discrimination (last updated January 6, 2022)

More in Health companies, vendors and employers