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Nutrigenetics guide

Judging genetic tests: lab and report quality

Reviewed by Dr. Daniel Wallerstorfer, molecular biologist and founder of Novogenia · Updated: 12 October 2026 · Reading time: 8 min

In short

A genetic analysis is only as good as three things: the measurement in the lab, the science behind each gene and the way the report puts the result into context. Check who does the measuring and to which standards, what evidence stands behind the genes, whether finding and recommendation are kept apart and how the data are handled. Important: certification and accreditation are not the same – ask what exactly was assessed.

40 percent wrong: why lab quality is not a detail

In a good laboratory, determining gene variants is routine today. How much depends on the right lab becomes clear when you look at a different route: a US laboratory looked at 49 cases in which people wanted results from consumer genetic tests confirmed clinically. The outcome: 40% of the variants listed in the consumer tests’ raw data were false positives. And some variants that a third-party service had labeled “increased risk” were classified as benign by several clinical laboratories (Tandy-Connor et al., Genetics in Medicine 2018).

For your counseling, this means: a genetic analysis is like a scale. If it measures wrong, even the best dietary advice is useless. Before you work with a provider, it pays to take a close look – at the lab, at the science behind the genes and at the report.

In the end, your client sees only the report, not the measurement behind it. You are their quality filter. This article gives you the questions you need to fill that role well.

Three touchstones for every genetic analysis

A simple framework has proven useful for evaluating genetic tests: the ACCE model. It asks about analytic validity, clinical validity, clinical utility and ethical, legal and social issues (Sanderson et al., Genetics in Medicine 2005; Burke et al., American Journal of Epidemiology 2002). Translated into your practice:

TouchstoneThe question behind itHow you recognize it
Analytic validityDoes the lab measure the gene variant correctly and reliably?a named lab, quality certificates, clear handling of samples and unclear results
Scientific validityIs the variant really linked to the trait?a disclosed selection rule, studies per gene, no claims without evidence
UtilityDoes the result help the person make a decision?concrete, actionable hints; honest labeling of conclusions
Ethics, law, data protectionAre consent, data access and boundaries properly handled?clear privacy information, no disease interpretation without a physician

Certified or accredited? A picture for the difference

Picture a restaurant kitchen. Certification checks whether the kitchen works to fixed processes: who buys, who checks, how mistakes get fixed? Accreditation goes further: it confirms that the kitchen can demonstrably prepare specific dishes properly. Both are valuable – but they are not the same.

CredentialWhat it confirmsWhat it does not confirm
ISO 9001 (certification)a working quality management system: processes are planned, monitored and continuously improvedtechnical competence for a specific laboratory examination
ISO 15189 (accreditation)quality and competence of a medical laboratory for specific examinations, confirmed by a national accreditation bodyexaminations outside the accredited scope
Working “according to ISO 15189”the lab aligns its processes with the standardconfirmation by an accreditation body
CLIA (USA)US certification for clinical laboratoriesthe scientific validity of individual genes in the report
National license for medical genetic analysesthe lab may perform medical genetic analysesthat every analysis the provider offers is medical

Our tip: ask to see certificates and read the scope. A logo on a website says little – the text on the certificate says it all.

Who actually measures? Lab, subcontractor, raw data

Which genes, which evidence?

Because there are no binding standards for nutrigenetics yet, an expert group has developed a framework to assess the scientific validity of a gene–diet claim and whether it is actionable (Grimaldi et al., Genes & Nutrition 2017). Until then, the provider’s selection rule is your most important guide.

At Novogenia, the three-study rule applies: a gene is only included in an analysis if at least three independent studies – by different researchers, in different population groups – show the same effect. How this works in detail is described in Explanation of the approach of science.

Ask every provider: what is your rule? Which studies stand behind this gene? And what happens to variants that are not sufficiently documented? Don’t be impressed by sheer volume: a report with hundreds of gene variants looks impressive but says nothing about how well each one is supported. Which genes are well supported in nutrition counseling is covered in The key genes for nutrition counseling.

Six features of a good report

Data protection: your client entrusts you with their recipe book

DNA is the most personal recipe book a person owns – and it also contains pages that concern parents, siblings and children. The GDPR therefore counts genetic data among the special categories of personal data (Art. 9 GDPR). Before working with a provider, clarify:

And for you yourself: never pass on results without the person’s consent – not to relatives, and not to colleagues. The legal details are covered in Genetic data and the GDPR.

Red flags: when you should get suspicious

Your provider check in six steps

Want to check a provider before recommending it to your clients? Here is how:

  1. Request credentials: Ask for the certificates and read the standard and scope.
  2. Ask about the lab: Where is the analysis done, who runs the lab, how does the sample travel?
  3. Spot-check the science: Ask for the studies behind two or three genes – for example LCT or MTHFR – and check whether they match the statements in the report.
  4. Read a sample report: Are finding and recommendation kept apart? Are limits named? Are promises to heal absent?
  5. Clarify data protection: Read the privacy information and consent form; agree in writing who sees which results.
  6. Test it yourself: Provide your own saliva sample and read your report through your clients’ eyes. What do you understand right away, and where do questions remain?

A reputable provider will gladly answer all these points – openly. That may be the best quality test of all.

Frequently asked questions

What is the difference between certified and accredited?
ISO 9001 certification confirms that a company has a working quality management system – it plans, monitors and improves its processes. ISO 15189 accreditation, granted by a national accreditation body, confirms the technical competence of a medical laboratory for specific examinations. So always ask: what exactly was assessed, and what is the scope of the certificate?
Why is Novogenia not accredited to ISO 15189?
Because no ISO 15189 accreditation exists for lifestyle analyses. Novogenia works according to ISO 15189, is CLIA-certified and holds the Austrian license for medical genetic analyses. Copies of the certificates are available on request.
Can I have raw data from a consumer test interpreted?
We advise against it. In a study by a US laboratory, 40% of the variants reported in raw data from consumer tests were false positives. Some variants labeled “increased risk” turned out to be benign on clinical review. Raw data are not designed for interpretation by third parties.
How many studies does a gene need to make it into a report?
There is no binding standard yet – but experts have developed a framework for assessing the scientific validity of gene–diet claims. Novogenia only includes a gene if at least three independent studies support the effect. Ask every provider about their rule and about the studies behind each gene.
Who sees my clients’ results?
That depends on the provider and should be agreed in writing beforehand. At Novogenia, you as the consultant decide whether you want to see your clients’ reports. In corporate health programs, the employer gets no insight into lifestyle analyses; medical analyses run only through a company physician, and only that physician sees the results.

Related: Quality assurance and certificates at Novogenia · Genetic data and the GDPR · How Novogenia selects genes

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