Laboratory at the YEARS clinic in Berlin

Category comparison

Genetic analysis or online DNA test?

Both are called a DNA test and in law they are not the same thing. German genetic diagnostics law draws the line, not provider marketing. This page compares the two categories without judging any individual provider.

§ 7

GenDG: physician requirement for predictive testing

§ 10

GenDG: genetic counselling before and after

170+

risk genes at YEARS, without polygenic scores

The short answer

Two products, two legal frameworks

An online DNA test gives you a report you have to interpret yourself. A genetic examination for medical purposes in Germany falls under genetic diagnostics law: predictive testing requires a physician, with mandatory information and genetic counselling before and after the result.

The practical difference therefore lies not in the laboratory but afterwards. The question is not who measures more variants, but who tells you what a variant means in your situation and what follows from it.

The comparison across five dimensions

Categories are compared, not providers. Third-party names and prices deliberately do not appear here.

DimensionMail-order DNA testPhysician-led analysis
Legal frameworkUsually shipped from abroad. Predictive health statements fall under German genetic diagnostics law; a pure mail-order test operates outside that.Under German genetic diagnostics law: physician requirement for predictive testing, information beforehand, genetic counselling before and after.
What is examinedA fixed grid of common variants, often by array. Good for ancestry and traits, limited for medically robust statements.More than 170 risk genes with clinical relevance, without polygenic risk scores. Whole-genome sequencing on request.
Who interprets the resultA report, usually with percentages and coloured bars. It leaves interpretation to you.A physician who sets the variant against your family history, your laboratory values and your medication.
What follows from itNothing binding. An abnormal report usually means the question only then reaches a physician.A recommendation in context: closer monitoring, a targeted additional examination, an adjustment to medication, or explicitly nothing.
Data processingFrequently transfer to third countries, sometimes with secondary use for research or commercial purposes. That sits in the terms, not the marketing copy.Processing in Germany, medical confidentiality, restrictions on use under German genetic diagnostics law.

Without black and white

What speaks for and against the mail-order test

What a mail-order test is genuinely good for

Ancestry, finding relatives and harmless traits are the actual purpose of these products, and for that they work. As a first prompt to look into your own family history they are not worthless either. That is simply something different from medical diagnostics.

Why a percentage without context says little

An elevated relative risk sounds dramatic and can still mean a very small absolute probability for a rare condition. Without the base rate the number cannot be interpreted. That base rate is exactly what a report usually does not supply.

What an abnormal finding actually sets off

A mail-order test can create a suspicion but cannot act on it. In practice what then begins is the path that a physician-led examination starts with: confirmation using a validated procedure, interpretation, family history, a decision about consequences.

Why we do not use polygenic risk scores

Polygenic scores add many small effects into a single number. How much they can tell you depends heavily on which population they were developed in, and they are not established for individual counselling. We therefore do not use them, although they would sell well.

What we examine specifically is set out on the genetic analysis page. How a genetic risk factor differs from a diagnosis is set out on genetic risk factors.

Legal basis

What this page refers to

  1. Gendiagnostikgesetz (GenDG), §§ 7, 8, 9, 10

    The legal framework: physician requirement for diagnostic and predictive genetic examinations (§ 7), consent (§ 8), information (§ 9) and genetic counselling (§ 10). The statute itself distinguishes the two categories compared on this page.

This page is a general orientation and not legal advice.

Common questions

The difference is not primarily technical but legal and substantive. A mail-order DNA test delivers a report you have to interpret yourself, usually shipped from abroad. A genetic examination in Germany falls under genetic diagnostics law: predictive testing requires a physician, there is mandatory information beforehand and genetic counselling before and after. In practice: a mail-order test gives you a number, a physician-led examination gives you an interpretation of that number against your family history, your laboratory values and your medication.

Buying a test abroad is not prohibited, and nobody commits an offence by ordering one. German genetic diagnostics law, however, governs the conditions under which genetic examinations for medical purposes may be carried out in Germany, and places predictive testing under a physician requirement with mandatory counselling. A provider delivering predictive health statements from abroad operates outside that framework. What that means for you above all: the safeguards the law provides do not apply to such a result. There is no mandatory counselling and no one to interpret the finding.

Yes, and it is often useful. An existing report belongs in the medical history, because it shows what is on your mind and which questions you bring. It does not replace a validated examination: variants from array-based methods are usually confirmed with a different procedure before anything follows from them medically. So expect an abnormal point in the report to be re-examined rather than adopted. The reverse holds too: a normal mail-order test is no reason to skip an indicated examination.

This is the difference least discussed and longest lasting. Genetic data cannot be revoked: you can change a password, you cannot change your germline variants. With mail-order providers, secondary use sits in the terms of service, frequently including transfer to third countries and use for research or commercial purposes, sometimes with the possibility that a dataset transfers on a change of ownership. With a physician-led examination in Germany, medical confidentiality and the restrictions on use under genetic diagnostics law apply. Read the data-sharing section for any provider before you hand over a sample.

Most of all when something could follow from the result. Concretely: with a family clustering of certain cancers or early heart disease, with unclear findings suggesting a hereditary cause, and before treatments whose tolerability is partly genetically determined. Without such a reason, the most likely effect is not a medical gain but a series of variants of uncertain significance that raise questions and answer none. That is not an argument against genetics but one for having an indication. We also say so in the intro call when there is none.

Already have a report and unsure what it means?

15 minutes, free of charge. Bring it along. We will also tell you when no further genetics is needed in your situation.

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