White-Label Home Testing

White-label home testing: lab tests under your brand

White-label home testing means: your customers order lab tests under your brand — test kit, shipping, sample return, lab analysis and digital results run invisibly on Probatix infrastructure. You keep the brand, the customer relationship and the data; Probatix handles kit production, fulfillment, accredited labs and result delivery via API.

2 weeks to launch ISO 15189-accredited partner labs REST API & FHIR R4 GDPR
The scope

What can be white-labelled?

Four layers on which your brand defines the user journey – while Probatix invisibly runs the operations in the background.

Kit, packaging & insert

Kit box, shipping packaging, instructions and inserts – produced and assembled entirely in your brand design. The end user sees your brand, not ours.

Glossary: white-label kit

Patient portal & results

Results page and lab report presentation in your brand’s look – with graphically prepared values, reference ranges and clear explanations.

Glossary: white-labelling

Shipping & returns

Outbound kit shipping and sample return to the lab – EU-wide, with full tracking. Probatix handles warehousing and kit assembly.

The logistics chain in detail

Result communication

Status updates and result notifications in your name – via API into your own app or through the white-label-ready portal.

Explore the lab diagnostics API
The process

How the launch works: ready in 2 weeks

From approved design to a ship-ready kit variant in about two weeks – the same timeframe in which partners like Yazen went live.

01

Define panel & design

You choose parameters and sample type; we check feasibility and the parameter-to-sample-type mapping. In parallel, you provide logo and brand guidelines for kit and packaging.

02

Kit production & approval

Probatix produces and assembles your kit variant following documented processes (works to ISO 13485) – including approval samples for sign-off.

03

Connect the integration

Partner portal for a no-code start, REST API with FHIR R4 results and webhooks for deep integration – you decide on the access route.

04

Live operations

Orders run automatically through fulfillment, ISO 15189-accredited partner labs and result delivery. You keep the brand, the customer relationship and the data.

Quality & regulatory

Standards your programme builds on

Analysis takes place exclusively in ISO 15189-accredited partner laboratories. Probatix itself works to ISO 13485 for kit manufacturing and assembly and to ISO 27001 for the platform’s information security. All data flows are designed to be GDPR-compliant; an adapted nDSG/LPD configuration applies for Switzerland.

IVDR responsibilities: Whoever places a test kit on the market under their own brand takes on regulatory obligations as the party placing it on the market. The exact division of responsibilities between your company, Probatix and the laboratories is agreed contractually per use case – the fundamentals are explained in our knowledge hub article IVDR & test kits.

Frequently asked questions

White-label test kits: FAQ

The six questions that come up most often in first conversations about white-label programmes.

What does a white-label test kit programme cost?

Costs typically consist of a one-time setup component (design, kit configuration, approvals) and a usage-based price per test. Unit costs depend on parameter scope, sample type, white-label depth and volume. We prepare a specific calculation in the demo call; the fundamentals are explained in our knowledge hub article on the costs of a diagnostics programme.

How quickly can we launch?

White-label kits are ready to ship in about two weeks once design and panel selection are approved. The integration runs in parallel: first orders can be created through the partner portal without any development effort, and an API integration typically takes 2–4 weeks.

Who carries the IVDR/MDR responsibility?

Probatix is responsible for kit manufacturing and assembly (works to ISO 13485) as well as logistics and platform operations. The ISO 15189-accredited partner laboratories carry the laboratory-medical responsibility for the analysis. Whoever markets a test kit under their own brand takes on the role of the party placing that product on the market – the exact division of responsibilities under the IVDR is agreed contractually per use case.

Can we put together our own panels?

Yes. Panels can be assembled freely from the available parameter catalogue – including requested values and adapted reference ranges. The choice of sample type follows the parameter: not every value can be measured reliably from capillary blood. Probatix advises on the parameter-to-sample-type mapping per panel.

How do the results get into our system?

Via the REST API as structured JSON or as a FHIR R4 bundle (DiagnosticReport and Observation, LOINC-coded). Webhooks report status transitions in real time. Alternatively, results are available in the partner portal and in the white-label-ready patient portal.

In which countries is this available?

Probatix is available in Germany, Austria and Switzerland. Shipping is EU-wide; Switzerland is served through the Steinhausen branch with an adapted data protection configuration (nDSG/LPD).

Your test kit. Your brand. Our infrastructure.

A demo, kit samples and a specific calculation for your white-label programme – in 30 minutes.