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Offering pharmacogenetics: the process from sample kit to the physician's decision
Offering pharmacogenetics means organizing a relay race: clarify roles and country, clarify the reason for testing, inform and obtain consent, take the saliva sample, analyze it in the lab and discuss the result. At Novogenia, the analysis runs in our own lab in Eugendorf near Salzburg and takes 4 days. Who orders the test depends on the country: in Germany only physicians, in Switzerland also pharmacists under conditions; in Austria, all our partners can offer purely pharmacogenetic analyses. Decisions about medication are always made by the treating physician.
From espresso to prescription: pharmacogenetics is a relay race
Roughly 95% of the caffeine you drink is broken down by a single liver enzyme, made from the blueprint of the CYP1A2 gene. If it works fast, the caffeine is cleared quickly. If it works slowly, the caffeine stays in the body far longer (Caffeine and the CYP1A2 gene). This very principle – fast and slow metabolizers – is behind pharmacogenetics. Only here, the question is not a cup of coffee but how a medicine works.
Turning that knowledge into a good decision takes a clean process. Think of it as a relay race: each station hands the baton to the next – from counseling to the sample kit and the lab to the result. The same person always runs the final leg: the treating physician, who makes the decision about medication. Here is how the race works with Novogenia.
The process in 6 steps
| Step | What happens | Whose turn it is |
|---|---|---|
| 1. Clarify roles and country | Who may order, who informs, where does the result go? | you and your team, with us |
| 2. Clarify the reason | a specific prescription or a pre-emptive test | the ordering professional |
| 3. Inform and obtain consent | purpose, handling of sample and data, sharing, withdrawal | the ordering professional and the patient |
| 4. Saliva sample | sampling with the kit, following the instructions | the patient, with you if desired |
| 5. Analysis | lab analysis in Eugendorf, 4 days | Novogenia |
| 6. Result and decision | put the result in context, review medication | the treating physician |
Step 1: Clarify roles and country – who runs which leg?
Before the first sample kit goes out, it is clear who may order the test in your country. The short version – in detail in Law: who may offer pharmacogenetics?:
- Germany: Pharmacogenetics is a diagnostic genetic examination that only physicians perform (Section 3 No. 7(c) and Section 7(1) GenDG). The lab discloses the result only to the commissioning physician (Section 11(2)).
- Austria: The Gene Technology Act does not require a specialist order for purely pharmacogenetic analyses. At Novogenia, all partners in Austria can offer purely pharmacogenetic testing.
- Switzerland: Pharmacogenetics belongs to the medical context (Art. 19 GUMG). Physicians, pharmacists and, within their field, dentists and chiropractors may order it, each under conditions (Arts. 5 to 8 GUMV).
Use this step to assign tasks in your team, too: who informs, who documents consent, who receives the result? If a medical practice and a pharmacy work together, agree on who runs which leg. You will find ideas in Pharmacogenetics in medical practice and Pharmacogenetics in the pharmacy.
Step 2: Clarify the reason – test now or ahead of time?
A test needs a question. Is a specific prescription coming up in which genes may play a role? Or should a result be ready for future prescriptions? Both routes have their place; their strengths are described in Pre-emptive or reactive testing?
Stay honest: genes are one factor among many. A pharmacogenetic result is a valuable building block for the treatment decision – not the decision itself.
Step 3: Inform and obtain consent
Before sampling, your patient knows what the analysis shows and what it does not, what happens to the sample and data, who receives the result and that consent can be withdrawn at any time. In Germany, consent is given explicitly and in writing to the responsible physician (Section 8 GenDG); in Switzerland, freely and expressly after adequate information (Art. 5 GUMG).
A practical tip: ask right away whether the result may go to other treating physicians or to the patient’s regular pharmacy, and record the answer. It saves detours later. Everything else is in Data protection and consent.
Step 4: The saliva sample – a little saliva is enough
For the analysis, the lab only needs a saliva sample, taken with a sample kit. For medical analyses, we use sample kits that are medical devices; for lifestyle analyses, there are separate non-medical-device kits. On request, the kits carry your branding, and physicians who work with us receive the appropriate sample kits.
The instructions in the kit always apply: they say what to observe before sampling and how the sample is clearly assigned to the right person. If your patient takes the sample in the practice or pharmacy, go through the instructions together and answer questions on the spot.
Step 5: Analysis in our lab in Austria
The sample goes to our own lab in Eugendorf near Salzburg. Novogenia has existed since 2009, and we have performed more than 30 million analyses. The lab analysis takes 4 days; add time for shipping and for discussing the result.
What you can rely on:
- Our lab is CLIA-certified and works according to ISO 15189.
- We hold the Austrian license for medical genetic analyses.
- A gene is only included in an analysis if at least three independent studies support the effect.
Which genes typically play a role in pharmacogenetics and how guidelines classify them is explained in Key genes: CYP2D6, CYP2C19 and more and Guidelines: CPIC, DPWG and drug labels.
Step 6: Result, discussion and the physician’s decision
You settled who receives the result in step 1. In Germany, it goes to the commissioning physician (Section 11(2) GenDG). In Switzerland, a physician or a specialist the physician authorizes communicates the result (Art. 26(1) GUMG); if a pharmacy ordered the test, the pharmacist does so personally (Art. 7(4) GUMV).
In the discussion, the result is put into context: which medicines does the patient take now, and which might be added later? The decision about stopping, switching or dosing is made only by the treating physician. Pharmacogenetics can support that decision – it does not replace it.
So that the result also helps with later prescriptions, give your patient an understandable summary and document the result carefully. How to explain results clearly is covered in Understanding and communicating results.
How to work with us: the partner models
Novogenia sells exclusively through partners – in 69 countries. There are three routes for your offer:
- Partner shop: You earn a commission per order, with no setup fees.
- White label: The analysis runs under your own brand; the sample kits can carry your branding too.
- Own product development: We develop a concept of your own with you.
For clinics, we offer an end-to-end process from a single source: sample kit, shipping, incoming inspection, analysis in our EU lab and delivery of results. The clinic concentrates on counseling, indication assessment and personal care. Which model fits pharmacogenetics also depends on the law in your country (step 1) – tell us about your setting and we will find the right route.
Get ready: NOVO Academy and podcast
The NOVO Academy is our free training program: around 5 hours of video per language, with a certificate for each completed topic; taking part is voluntary. For pharmacogenetics, there is the “Drug Intolerance” lecture. In it, Dr. Daniel Wallerstorfer explains why medicines work differently in different people, how CYP enzymes break down active substances and what “fast” and “slow” metabolizers are. The lecture is currently available in English, Czech, French, Portuguese, Italian and Dutch, but not yet in German (NOVO Academy).
Another way in is episode 6, “Pharmacogenetics,” of our podcast – with codeine as the classic example of a prodrug that the body must activate first. Note: the podcast was created with AI, based on the book by Dr. Daniel Wallerstorfer; the voices are synthetic.
Checklist for your start
- You know who may order the test in your country and have assigned tasks in your team.
- The reason for the test is clear – a specific prescription or ahead of time.
- Information and consent are prepared, including the question of sharing the result.
- Sample kits are at hand, and you know the instructions.
- The route of the result is set.
- Time is planned for discussing the result; changes to medication go through the treating physician.
- The right partner model is chosen.
- Your team is prepared, for example with the NOVO Academy.
Frequently asked questions
How long does the analysis take?
Can I offer pharmacogenetics under my own brand?
Who decides about medication after the result?
Is there pharmacogenetics training in English?
Do I need my own lab?
Related: Pharmacogenetics in medical practice · Law: who may offer pharmacogenetics? · Pharmacy guide
Pharmacogenetics in your practice or pharmacy?
Tell us about your setting – we will show you how the offer can work for you.
Request a project →Offer for physiciansNote: 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. Pharmacogenetic results do not replace a medical decision: any change to medication is made only by the treating physician. Regulations can change; errors and changes excepted.
