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Contract lab: genotyping and raw data on demand – when it fits you
A contract lab measures what you specify: you define the markers, the lab extracts the DNA, genotypes it and delivers structured results – as raw data in the format your platform or pipeline needs, or as a finished report. That fits brands with their own interpretation, diagnostics and biotech companies that need capacity, and clinics that keep medical responsibility. You agree on method, throughput and timeframe at the start, and you can begin with a test run. The key distinction: genotype data from an agreed lab order are something different from raw data from consumer tests – we do not recommend having those interpreted by third parties.
You write the book, the lab prints it
Not every genetic-test brand needs a lab of its own. Some companies have their own interpretation, their own algorithm, their own platform – all they are missing is the measurement. Some clients even supply already extracted DNA and only need the genotyping.
For them, a contract lab works like a good print shop: you deliver the manuscript, the print shop prints it precisely, in any run size. Content and publishing stay yours. Translated, that means: you decide which markers are measured and what happens with the results. The lab makes sure every measurement is right, every sample stays traceable and the data arrive in your format.
This article shows you what a contract lab takes on, what you get back, why raw data are not all the same, and when a contract lab fits better than a white-label report.
What a contract lab takes on for you
A contract lab is modular. You can commission the whole chain – or only the steps you are missing:
| Service | What happens | What you get |
|---|---|---|
| Sample logistics | saliva collection kits, shipping, receipt, registration and storage of samples – or you deliver ready-prepared samples | uniquely traceable samples |
| DNA extraction | clean preparation and extraction of DNA from saliva or other sample materials | DNA ready for genotyping |
| SNP genotyping | targeted determination of the markers you choose, reproducible and scalable to high throughput | genotypes of your markers for every sample |
| Data delivery | structured results as raw data or as a finished report | data in the format of your platform or report |
| Test development | marker selection, panel design, assay development, validation, pilot and scale-up | a new test, with a report under your brand on request |
Who benefits? Brands and providers of health or DNA tests that do not want to run their own lab. Diagnostics and biotech companies with short-term capacity needs. And clinics, hospitals and health projects looking for a contract lab with logistics from sample to result. How a new test is developed is described on the page Development partner for genetic analyses.
Raw data or finished report: what you get back
Every order ends with a data delivery. You have two options:
- Raw data: structured genotype results that your platform, algorithm or pipeline processes further. Interpretation then lies with you – and with it, responsibility for what you tell your customers.
- Finished report: The lab also takes on interpretation and the report. That is the step to white label, more in Reports and platform under your brand.
For raw data, one simple rule applies: the format follows your system, not the other way around. You agree together at the start on which formats, annotations and identifiers your platform expects. Put in writing:
- the marker list and how each marker is labeled,
- the sample identifiers and how they map to your customers or study participants,
- file format, structure and transfer route,
- how results that cannot be determined unambiguously are flagged.
A middle path: If your company already holds usable genotype data, Novogenia can interpret them directly and move straight on to the formula for personalized products. Novogenia handles the step from genotype to recommendation as a service, rather than shipping you a piece of software. Ownership of the SNP data and the customer relationship stay with you.
Raw data are not all the same
The term “raw data” covers two very different things. How big the difference is shows in a review by a US lab: it looked at 49 cases in which people wanted results from consumer genetic tests clinically confirmed. 40% of the variants reported in the consumer tests’ raw data turned out to be false positives. Some variants that a third-party service had classified as “increased risk” were considered benign by several clinical labs (Tandy-Connor et al., Genetics in Medicine, 2018).
The good news is in the same study: the authors stress how important a lab is that can reliably detect and classify variants. That is exactly the core of a contract lab order. The measurement is made for your question, with agreed markers and a checked process:
| Question | Genotype data from the contract lab | Raw data from consumer tests |
|---|---|---|
| Who decides what is measured? | you, together with the lab | the test provider, for its own report |
| What is the measurement made for? | for your platform, your report or your study | for the provider’s report, not for interpretation by third parties |
| Can you trace the process? | method, sample identification and data format are agreed and documented | The process lies with the test provider; you cannot shape it. |
That is why the nutrigenetics guide advises against having raw data from consumer tests interpreted: they are not made for interpretation by third parties. This does not contradict the contract lab – it is its counterpart. If you want to interpret data, have them measured for that purpose.
When a contract lab fits – and when white label does
The question is not which model is better, but what you are missing. Whether pure contract analysis, joint development or a white-label solution – the collaboration follows your model:
| Your situation | Model that fits |
|---|---|
| You have your own interpretation, algorithm or platform – only the measurement is missing. | contract lab with raw data |
| You have a brand and customers, but no interpretation of your own. | white label with a finished report – see Building your own genetic-test brand |
| You need extra lab capacity at short notice. | contract lab for single steps or series |
| You want to develop a new test. | development partnership, with a report under your brand on request |
| You are planning a study or cohort. | genotyping for research – see Genotyping for research and studies |
Medical orders: who carries the responsibility?
When a clinic works with a contract lab, medical assessment, counseling and the decision on indication remain the clinic’s responsibility. The lab measures; medicine stays with the physician.
In Germany, this is set down in law. Within the scope of the Genetic Diagnostics Act, for example for examinations for medical purposes, the genetic analysis of a sample may only be carried out as part of a genetic examination by the responsible physician or by persons and institutions that physician has commissioned (Section 7(2) GenDG). The commissioned lab communicates the result only to the physician who commissioned it (Section 11(2) GenDG). For medical contract orders, that means: the order comes from the physician, and the results go back to the physician.
In Switzerland, prescribing physicians and laboratories may transfer all or part of a genetic test to a lab abroad if it works according to the state of the art in science and technology, has an appropriate quality management system, is authorized to perform such tests in its country, and the person concerned has given written consent (Art. 29 GUMG). So plan for written consent for Swiss samples from the start.
The GenDG does not apply to genetic examinations for research purposes (Section 2(2) no. 1); what matters there is described in Genotyping for research and studies. How Germany, Austria and Switzerland draw the line between lifestyle and medicine is shown in Law: offering genetic tests in DE, AT and CH.
From the first conversation to ongoing analysis
A contract lab project does not start with the first sample, but with clear agreements:
- Scoping: Which markers, which sample material, which volumes? Method, throughput and timeframe are set here.
- Data format: Raw data or report? Formats, annotations and identifiers are agreed in writing.
- Logistics: kits and shipping through the lab – or delivery of prepared samples or extracted DNA.
- Test run: A first run shows whether samples, data and systems fit together.
- Ongoing analysis: Then you scale up – without reproducibility or delivery time suffering.
The 4 days apply to the Novogenia standard analysis. For contract projects, the timeframe you agree in scoping applies. The same principle holds for the quote: transparent and with volume tiers, matched to your volume.
Checklist: questions for your contract lab
- Where exactly is the analysis done, and who carries out each step?
- Which quality certifications are there – and what does the scope of the certificates say? More in Choosing the right lab.
- How does every sample stay traceable from collection to result?
- Which markers, which method, which throughput, which timeframe?
- In which format, with which identifiers and by which route do the data arrive?
- How are results that cannot be determined unambiguously flagged?
- Who is responsible for the genetic data? More in Data protection for white-label genetic tests.
- How do you get from the test run to ongoing analysis, and what do the volume tiers look like?
Frequently asked questions
What is the difference between a contract lab and white label?
In which format will I receive the raw data?
Can I supply already extracted DNA?
Do you interpret raw data from consumer tests?
How long does a contract analysis take?
Related: Genotyping for research and studies · Judging genetic tests: lab and report quality · Contract lab for genetic analyses
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Request a project →White-label genetic analysesNote: 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.
