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Choosing the right lab: quality criteria for your genetic-test brand

Reviewed by Dr. Daniel Wallerstorfer, molecular biologist and founder of Novogenia · Updated: 13 October 2026 · Reading time: 10 min

The foundation no one sees

How reliable is genotyping, really? A research team at the University of Exeter tested this with 49,908 participants in the UK Biobank. They compared results from SNP chips – a widely used method that determines many gene variants at once – with sequencing data from the same people. For 108,574 common variants, sensitivity, specificity and both predictive values were all above 99%. For very rare variants, with a frequency below 0.001%, sequencing confirmed only 16% of the chip results in which one of the two gene copies was altered (Weedon et al., BMJ, 2021).

The logical conclusion: genotyping can be extremely reliable – when the method fits the question and the lab validates its results. For your brand, that is good news and a mandate at the same time.

A lab is like the foundation of a house: no one sees it, but everything rests on it. Your customers see your logo, your design and your report. Whether the results are right is decided by the lab behind them. This article shows you how to recognize a solid foundation.

Eight criteria at a glance

The following sections go through the criteria – and show for each one how it looks at Novogenia.

Reading certificates: CLIA, ISO 15189 and ISO 9001

A logo on a website says little; the text on the certificate says it all. Ask to see the documents and read the scope. These four come up most often:

CLIA and the licenses allow Novogenia to carry out medical genetic analyses and to serve customers worldwide, including in the US. How certification and accreditation differ in principle is explained with a simple picture in How to assess genetic tests. If you need copies for a tender, an audit or your own compliance review, we are happy to provide them.

Genes and method: the rule matters more than the number

A lab can measure a variant perfectly – and still deliver a weak report if the gene behind it has barely been studied. So ask about the rule that decides which genes go into an analysis.

At Novogenia, the three-study rule applies: a gene is included in an analysis only if at least three independent studies support the effect. We do not report variants that are not sufficiently documented. For your brand, this means: every statement in the report has a traceable scientific reason. We label the recommendations drawn from it honestly as logical conclusions, not as proven.

The method matters just as much. The study from the beginning shows it: the same technique that determines common variants extremely well can miss the mark with very rare variants. A good lab chooses the method to fit the variants and checks it before releasing results. For new tests, Novogenia develops and optimizes the assay in its own lab until sensitivity and specificity meet your requirements – in other words, until true hits are reliably detected and false alarms are avoided. A structured validation of reproducibility and robustness follows.

The sample route: from kit to result

Between your customer’s saliva and their report lies a route with several stops. Ask how the lab secures each one:

• Kit: Is it classified for your purpose – as a non-medical device for lifestyle analyses or as a medical device for medical analyses? Can people collect the sample reliably without trained staff?
• Receipt: How are samples registered and checked on arrival?
• Assignment: Does every sample remain clearly traceable from kit to report?
• Exceptions: What happens if a sample cannot be analyzed – and who informs your customer?

At Novogenia, the kits are assembled in the lab in Eugendorf near Salzburg and, on request, linked directly to sample logistics and analysis – all from a single source. The sample’s route is described in detail in Sample logistics: from kit to lab; the classification of kits is explained in Saliva kits: medical device or not?.

Speed and growth: turnaround and scaling

For your customers, what counts is how fast the report arrives. For you, it also matters whether the lab grows with you. Ask about both – and have specific details written into the quote.

At Novogenia, the standard analysis takes 4 days. For custom panels, contract-lab orders or research projects, we agree on method, throughput and timeframe in the project. You can start with a test series and scale up the ongoing analysis later.

Data protection and location: where samples and data stay

Genetic data belong to the special categories of personal data. Processing them is prohibited in principle unless an exception applies – such as the explicit consent of the person for specified purposes (Art. 9 GDPR). If a lab processes data on your behalf, you may only use a processor that provides sufficient guarantees for appropriate technical and organizational measures; the basis for this is a contract (Art. 28 GDPR).

So clarify before launch: Where is the sample analyzed, and where are the data stored? Who is the controller, and who is the processor? Who sees the reports? At Novogenia, every sample is analyzed in our own lab in Austria, under European data protection law. And you decide whether you see your customers’ reports. Everything else on roles, consent and retention is in Data protection for white-label genetic tests.

For offers in Switzerland, a lab in Austria is a lab abroad. The Swiss Federal Act on Human Genetic Testing allows this but attaches conditions: the lab must perform the test according to the state of the art in science and technology, have a suitable quality management system and be authorized in its own country to perform such tests; and the person concerned must have consented in writing (Art. 29 GUMG). For tests of particularly sensitive characteristics outside the medical field, this applies accordingly (Art. 36 GUMG). For all tests outside the medical field, the person must also be informed in writing about the performing lab and about companies and laboratories abroad that are involved (Art. 32 GUMG). How this differs from Germany and Austria is covered in Law: offering genetic tests in DE, AT and CH.

Who does what? Clarify roles openly

A good lab tells you openly who handles which step – especially where lifestyle and medicine meet. At Novogenia, it works like this:

• Lab analysis: Novogenia GmbH, in its own lab.
• Non-medical analyses: Novogenia analyzes and interprets the lab data, for example on nutrition, metabolism, skin, sport and lifestyle.
• Medical analyses: Physicians handle interpretation and medical reporting; the performing lab and the reporting body are named in the medical report.
• Sales: Partners offer non-medical analyses, under their own brand or through a partner shop.

Ask every lab about this division of tasks. It determines what you may promise, who appears in the report and who is responsible for which data. If you have your own interpretation and only need genotyping and raw data, read Contract lab: genotyping and raw data on demand.

Your lab check: twelve questions before you sign

• Is the lab named, and does it analyze your samples itself?
• Which certificates are in place – with which scope and from which body?
• “Accredited” or “working according to ISO 15189”: what exactly is meant?
• Is the lab allowed to perform medical genetic analyses, in case you need them?
• By what rule do genes make it into the analysis – and what happens to weakly documented variants?
• Which method determines the variants, and how was it validated?
• How are samples registered, checked and clearly assigned?
• What happens if a sample cannot be analyzed?
• How long does the analysis take – and how is the timeframe for special projects set?
• Where are samples and data processed, and who is the controller, who the processor?
• Who interprets medical analyses, and who is named in the medical report?
• If you sell in Switzerland: are the conditions for a lab abroad met?

Frequently asked questions

Related: Quality assurance and certificates · How to assess genetic tests · Contract lab for genetic analysis

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.