Law: offering genetic tests under your own brand in Germany, Austria and Switzerland

Reviewed by Dr. Daniel Wallerstorfer, molecular biologist and founder of Novogenia · Updated: 13 October 2026 · Reading time: 11 min

In short

For your own genetic-test brand, the purpose of each analysis decides which rules apply. You can offer lifestyle analyses on nutrition, sport or well-being under your brand. Medical analyses go through physicians wherever the law requires it: in Germany with a physician reservation, consent, information and counseling (Sections 7–10 GenDG); in Austria, types 3 and 4 only in approved facilities when ordered by a specialist (Section 68 GTG). Switzerland also regulates lifestyle analyses: certain health professionals order them, the sample is collected in their presence, home tests are ruled out, and the written information names the lab (Arts. 13, 32 and 34 GUMG).

Your brand is the facade – the law is the structure

With white label, the kit, the report and the platform carry your brand. Logo, colors, packaging and tone of voice are the facade of your house – and you design it. You do not design the structure, which decides which walls carry the load: who may order an analysis, who communicates the result, which lab must be named, and whether a kit may be mailed to your customer at all.

Germany, Austria and Switzerland build that structure differently, but from the same starting point: the purpose decides, not the lab technique. A power-versus-endurance analysis follows different rules from a disease-risk analysis – even from the same saliva sample. Here is what that means for your brand; it is orientation, not legal advice. For the practitioner’s view, see Who may offer genetic tests?.

The first question: lifestyle or medical?

Before you finalize your portfolio, classify every analysis; each law draws the line differently:

Country	When an analysis is medical	Legal basis
Germany	It is meant to clarify, among other things: an existing disease or health disorder, genetic traits that can trigger a disease or health disorder together with external factors, traits that can influence the effect of a medicinal product, or a disease that will only occur in the future.	Section 3 Nos. 7 and 8 GenDG
Austria	It allows statements about carrier status, a disease risk, an existing disease or the course of a disease or therapy.	Section 4 No. 23 and Section 65 GTG
Switzerland	Diagnostic, presymptomatic and prenatal tests and other tests for medical purposes – explicitly including topics such as food intolerances, metabolic disorders or an increased risk of sports injuries.	Art. 19 GUMG, Art. 37(2) GUMV

What counts is what the analysis is meant to clarify and how the report words the result. A report that turns a nutrition question into a statement about disease risk switches lanes. Which topics suit your brand: Choosing the right test portfolio.

Germany: medical genetic tests are a physician’s service

The Genetic Diagnostics Act (Gendiagnostikgesetz, GenDG) applies to genetic examinations for medical purposes, for clarifying parentage, and in insurance and employment (Section 2(1)); analyses serving none of these purposes, such as power versus endurance type, are not listed. For anything medical, the act sets up a fixed chain:

Physician reservation (Section 7(1)): Only physicians perform diagnostic examinations; only specialists in human genetics or suitably qualified physicians perform predictive ones.
Lab on assignment (Section 7(2)): The responsible physician performs the genetic analysis or assigns a person or facility to do so.
Consent (Section 8): explicit and in writing, given to the responsible physician. The assigned lab may only analyze once it has proof of consent.
Information and counseling (Sections 9 and 10): The physician first explains purpose, informative value and risks, including the right not to know. For predictive examinations, genetic counseling before and after is mandatory unless the person waives it in writing.
Communicating the result (Section 11): The person tested learns the result from the responsible physician. The lab reports it only to the physician who assigned the analysis.

So in Germany, medical analyses are a physician’s service: your brand can neither give the information nor communicate the result. Pharmacogenetics explicitly counts as a diagnostic examination (Section 3 No. 7(c)) – more in the pharmacogenetics guide.

Austria: four types and a license

In Austria, the Gene Technology Act (Gentechnikgesetz, GTG) regulates genetic analyses in humans. A “genetic analysis” is a lab analysis that allows statements about carrier status, a disease risk, an existing disease or the course of a disease or therapy (Section 4 No. 23). For medical purposes, Section 65(1) distinguishes four types – from type 1 (acquired, somatic changes) to type 4 (a predisposition to a disease for which neither prophylaxis nor therapy is possible).

Types 3 and 4 – analyses of a predisposition to a disease or of carrier status – may only be performed in facilities approved for them and only when ordered by a specialist in human genetics/medical genetics or in the relevant field (Section 68(1) GTG).
Types 2 to 4 require the person tested to confirm in writing that a specialist informed them and that they consented, plus counseling before and after the analysis and an individual counseling letter (Section 69 GTG).
Confidentiality: Anyone who performs or orders genetic analyses or processes the resulting data keeps them confidential; they go only to the persons listed in the act, such as the person tested and the ordering physician, and to others only with express written consent (Section 71 GTG).

Analyses allowing none of these statements fall outside Section 4 No. 23. Section 65 GTG does not name pharmacogenetics explicitly; for its classification in Austria, see the pharmacogenetics guide.

Switzerland: who prescribes, where is the sample taken, who is named?

Switzerland regulates genetic testing in the Federal Act on Human Genetic Testing (GUMG) and its ordinance (GUMV) – explicitly outside medicine too, unlike Germany and Austria. The GUMG has three categories:

Medical context (Art. 19 GUMG): As a rule, physicians prescribe these tests (Art. 20); the result is communicated by a physician or by a specialist the physician authorizes (Art. 26). Public advertising for them is banned; the ban does not apply to persons authorized to prescribe them (Art. 14(1) and (2)).
Sensitive characteristics (Art. 31(1) GUMG): among others, physiological characteristics which, if known, may influence a person’s lifestyle – according to Art. 37(1) GUMV, in particular eating behavior, physical activity and general well-being. This is where typical lifestyle analyses sit.
Other tests (Art. 31(2) GUMG): for example hair and eye color or the senses of smell and taste (Art. 37(3) GUMV).

Lifestyle analyses in the middle category come with rules that shape your business model:

Only health professionals prescribe (Art. 34 GUMG, Art. 40 GUMV): physicians, pharmacists, psychologists, druggists HF and – for physiological characteristics – nutritionists FH, physiotherapists FH, chiropractors and osteopaths, each authorized to practice under their own professional responsibility and working in the relevant field.
Sample in their presence (Art. 34(3) GUMG): The sample is collected in the presence of the person prescribing the test.
No home tests (Art. 13 GUMG): Self-tests may only be supplied for other tests, so a kit mailed to your customer and used alone at home is ruled out for lifestyle and medical analyses.
The lab is named (Art. 32 GUMG): The written information names the performing lab and any companies and labs abroad involved in the test or processing the genetic data, plus contact details of a specialist for questions and of the person responsible for data processing.
Lab abroad (Arts. 36 and 29 GUMG): allowed if it works to the state of the art in science and technology, has a suitable quality management system and is authorized in its own country – and the person concerned has consented in writing. A lab in Switzerland needs authorization from the Federal Office of Public Health (Art. 35).
Only what fits the purpose (Art. 33 GUMG): Only results that relate to the purpose of the test are disclosed.
Advertising with mandatory information (Art. 14(3) GUMG, Art. 4 GUMV): Advertising to the public must, among other things, explain the rules on prescription, information and disclosure of results and must not mislead. More in Advertising genetic tests.

Three countries, one brand: the comparison

Question	Germany	Austria	Switzerland
Lifestyle analyses (nutrition, sport, well-being)	not listed in the scope of the GenDG (Section 2(1)); mind the boundary in Section 3 No. 7	not covered as long as they allow no statements under Section 4 No. 23 GTG	only via health professionals listed in Art. 40 GUMV, sample collected in their presence (Art. 34 GUMG)
Medical analyses	physician reservation (Section 7); consent, information, counseling (Sections 8–10)	types 3 and 4: approved facility, specialist order (Section 68); types 2–4: information and counseling (Section 69)	prescribed by physicians (Art. 20); lab authorization (Art. 28)
Communicating the result	the responsible physician to the person tested (Section 11)	only to the persons listed in Section 71(2) or with written consent	medical: by a physician or an authorized specialist (Art. 26); otherwise only results that fit the purpose (Art. 33)
Employers and insurers	may not require tests or receive or use results (Sections 18, 19; exception for very high insured sums)	collecting, requesting, accepting and using results prohibited (Section 67; narrow exception for type 1 results for insurers)	may not require non-medical tests or request or use medically irrelevant data (Art. 37)

What this means for your white-label brand

The structure translates into clear building rules for your offer:

Lifestyle under your brand: You can offer analyses on nutrition, weight, sport, stress and skin under your own name, with kit, report and, on request, a platform in your design; in Germany and Austria, the lab stays in the background.
Medical only through physicians: Where national law requires it, medical analyses go through physicians. Do not promise an invisible solution here: for medical preventive analyses, the medical report names the performing lab and the reporting body.
Switzerland as a project of its own: Direct-to-consumer kits do not fit lifestyle analyses there; a model in which professionals listed in Art. 40 GUMV – such as pharmacists or druggists HF – prescribe the analysis and collect the sample in their presence does. Because the written information names the performing lab (Art. 32 GUMG), the promise that “the lab stays invisible” does not fully apply in Switzerland – nor does the pure home kit.
The kit fits the purpose: Lifestyle and medical analyses use differently classified sample kits – more in Saliva kits: medical device or not?.
Your words, your responsibility: Selling under your own name means owning your communication: lifestyle results are a report, not a medical finding, and advertising promises neither diagnosis nor cure.
Data protection from day one: Genetic data are specially protected, even in lifestyle analyses – more in Data protection for white-label genetic tests.

Checklist: before your brand launches

Every analysis in the portfolio is classified as lifestyle or medical – for every country you sell in.
Lifestyle reports stay within their purpose and make no statements about disease risks.
Medical analyses go through physicians where the law requires it, including information, consent and the result.
For Switzerland: a prescribing professional under Art. 40 GUMV, sample collection in their presence, written information under Art. 32 GUMG, written consent to a lab abroad.
Advertising in Switzerland includes the mandatory information under Art. 14(3) GUMG and Art. 4 GUMV; there is no public advertising for medical tests.
Employer and insurer offers are designed so that these receive no genetic results.
The classification of the kit fits the purpose of the analysis.
Data protection roles between brand and lab are clarified in writing before launch.
When in doubt, ask a specialized lawyer or the competent authority.

How we do it at Novogenia

How we classify analyses for partner brands at Novogenia:

A clear line: Under their own brand, partners offer non-medical analyses – lifestyle, nutrition, beauty, sport. Where national law requires it, we provide medical analyses only through physicians.
Who does what: Novogenia GmbH performs the lab analysis and interprets non-medical analyses. Medical analyses are interpreted and reported by physicians.
Medical preventive analyses are only performed once the legally required medical information or genetic counseling has taken place and written consent has been given (Section 69 GTG or Sections 8–10 GenDG).
No diagnosis: Non-medical analyses are not a diagnosis or medical advice and do not replace a medical examination.
Minors: only non-medical analyses, and only with the written consent of the persons with parental responsibility.
License and quality: We hold the Austrian license for medical genetic analyses, are CLIA-certified and work according to ISO 15189.

Frequently asked questions

Can I sell medical genetic tests under my own brand?

Where national law requires it, medical analyses go through physicians: in Germany under Section 7 GenDG, in Austria for types 3 and 4 under Section 68 GTG, and in Switzerland under Art. 20 GUMG. In Switzerland, advertising medical genetic tests to the public is also prohibited; the ban does not apply to persons authorized to prescribe them (Art. 14 GUMG). Under your brand, you offer lifestyle analyses.

Can I mail saliva kits to consumers in Switzerland?

Not for analyses on nutrition, sport and well-being: they are prescribed by a health professional listed in Art. 40 GUMV, and the sample is collected in that person’s presence (Art. 34(3) GUMG). Self-tests may only be supplied for other tests, such as hair color or sense of taste (Art. 13 GUMG). Medical tests are prescribed by physicians (Art. 20 GUMG).

Does the lab have to be named if I offer a white-label test?

In Switzerland, yes: the written information names the lab performing the test and any companies and labs abroad involved (Art. 32 GUMG). For medical preventive analyses, the medical report names the performing lab and the reporting body. For lifestyle analyses in Germany and Austria, the lab stays in the background; your privacy notice must still name the recipients or categories of recipients (Art. 13(1)(e) GDPR).

May a lab in Austria analyze samples from Switzerland?

Yes, under conditions: the lab works to the state of the art in science and technology, has a suitable quality management system, is authorized in its own country, and the person concerned has consented in writing (Art. 36 with Art. 29 GUMG). A lab in Switzerland, by contrast, needs authorization from the Federal Office of Public Health (Art. 35 GUMG).

What applies if an employer or insurer offers my genetic tests?

As a rule, employers and insurers may not receive or use genetic results: in Germany under Sections 18 and 19 GenDG (with an exception for very high insured sums), in Austria under Section 67 GTG and in Switzerland under Art. 37 GUMG. Design the offer so that only the person tested receives the result.

Planning your own genetic-test brand?

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Note: This guide is general information for businesses and professionals and does not replace medical or legal advice. The genetic traits determined in a genetic analysis are well documented (each gene included is backed by at least three independent studies); recommendations derived from them are logical conclusions, not scientifically proven. Regulations can change; errors and changes excepted.