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Guide · Diagnostics-as-a-Service

Diagnostics-as-a-Service: Lab diagnostics as infrastructure

Diagnostics-as-a-Service (DaaS) is an infrastructure model in which lab diagnostics – sampling, logistics, lab analysis, and result delivery – is consumed as one integrated service via a single platform. Instead of building lab contracts, logistics, and software integrations in-house, providers consume the full stack via API or portal and ship tests live in two to six weeks. Probatix runs this stack: 25M+ processed analyses, ISO 13485 / 27001-certified, accredited partner labs under ISO 15189, FHIR R4-capable.

25M+ analyses ISO 13485 / 27001 <48h result FHIR R4 GDPR
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The process

How DaaS works

Four stages, fully orchestrated. Each is operationally well-defined – so providers know what they outsource and what stays in their hands.

01

Ordering

A test is triggered – via REST API, the partner portal, or a white-label webshop. The provider chooses the access path that fits their user journey. Operationally, Probatix creates the order in the backend, validates required fields, and reserves the kit variant.

REST API Partner portal Webshop
02

Shipping

The white-label kit is shipped EU-wide directly to the end user – with full tracking and packaging aligned to the provider's brand. Probatix handles warehousing, packing, and logistics provider integration. There is no inventory burden on the provider.

EU-wide Full tracking White-label
03

Lab analysis

The sample arrives at an ISO 15189-accredited partner lab. Probatix routes automatically by capacity, region, and parameter specification. Pre-analytics, validation, and medical release follow established standard processes – with documented quality metrics per batch.

ISO 15189 <48h turnaround Multi-lab routing
04

Result delivery

Results are returned structured – as JSON via the API, as a FHIR R4 bundle for interoperable systems, or via the patient portal. Webhooks notify in real time on status changes. The provider decides how to present the result to the end user.

JSON FHIR R4 Webhooks
Comparison

DaaS vs. own lab infrastructure vs. direct-lab integration

Three ways to integrate lab diagnostics into a product. Which one fits depends on volume, time-to-market, and the existing organisation.

Criterion DaaS (Probatix) Own infrastructure Direct lab integration
Time-to-market 2–6 weeks to go live 12–24 months to build and certify 4–8 weeks per lab integration
Initial investment Low – no hardware, no contracts High – devices, space, staff, QMS Medium – integration project per lab
Compliance burden Carried by the provider (ISO 13485 / 15189) Fully with the operator Split, contracts are complex
Scaling Elastic via multi-lab routing Bound to own capacity Renegotiated per lab
Sample types Capillary, venous, DBS, saliva, urine Whatever the own lab is accredited for Depends on contractor
White-labeling Kit, portal, report, shipping packaging Fully self-managed Rarely available

When DaaS does not pay off

For very high, steady volumes with a clearly bounded parameter set, an in-house lab can be more cost-effective long term – if the organisation is willing to carry the regulatory load and the QM system anyway. Pure point-of-care diagnostics in acute settings (e.g. emergency departments with bedside devices) also do not fit a DaaS model. DaaS plays to its strengths with elastic volume, broad parameter mix, and home-sampling workflows.

Building blocks

The building blocks of a DaaS stack

DaaS is not a single product but six components working together. Each exists as a stand-alone solution – the operational advantage comes from their integration.

White-label test kits

Custom-branded test kits incl. instructions, packaging, and return logistics. From order to ship-ready kit variant in two weeks.

White-label details

Home sampling & sample types

Capillary blood (Tasso+, TAP Micro Select), dried blood spot, saliva, urine. Sample type is chosen by parameter, not by user comfort.

Sample types in detail

Accredited partner labs

ISO 15189-accredited labs with documented pre-analytics, validated methods, and a unified report structure across all sites.

Lab orchestration

API & FHIR integration

REST API for ordering, status, and results. FHIR R4 bundle for clinical systems. Webhooks for real-time status updates. Integration in days, not months.

API overview

Fulfillment & logistics

Warehousing, packing, EU-wide shipping, return logistics, sample intake control. Operational complexity stays with Probatix.

See the infrastructure

Partner portal & patient interface

No-code access to the platform: ordering, tracking, result delivery. Optional white-label for end users.

Explore the platform
Who it fits

Who DaaS is for

DaaS is not a vertical product. It is an infrastructure layer that solves different problems depending on segment.

Digital health & longevity

Platforms like Yazen embed lab values directly into therapy and coaching workflows – without running their own lab or logistics team.

Telemedicine

Diagnostics closes the gap between video consultations and clinical decisions. Structured results flow automatically into the care pathway.

Health apps

Biomarker-based features in consumer apps – without the app team becoming a health-tech company itself.

Insurance providers

Prevention programs, bonus programs, and digital care offerings built on validated lab data – privacy-compliant and audit-ready.

Medical practices & MVZ

Extend existing practice workflows with home sampling and digital result delivery – no new LIS, no in-house development.

Supplement brands

Personalised supplement and prevention concepts based on real biomarkers, not self-reporting. Better adherence, fewer returns.
Compliance & quality

Standards DaaS builds on

DaaS does not shift compliance load – it concentrates it where the value creation happens. Probatix operates under ISO 13485 for manufacturing and assembly of test kits and ISO 27001 for platform information security. Analysis is performed by ISO 15189-accredited partner labs that carry their own laboratory-medical responsibility.

For data protection, GDPR applies across Germany and the EU. Switzerland is served via the Steinhausen branch under nDSG/FADP, with dedicated data storage. The Data Processing Agreement (DPA) governs data handling between provider, Probatix, and the analysing labs.

MDR/IVDR scope: The split of regulatory responsibility between Probatix as a platform and the customer as placer-on-the-market of a co-branded end product is set per use case in the contract.

Checklist

Choosing a DaaS provider: 8 criteria

A short self-checklist before any RFP. Robust answers to all eight signal a real infrastructure provider, not a reseller dressed up as one.

  1. 01

    Partner-lab accreditation

    ISO 15189 is the standard for medical labs. Check whether the accreditation covers the specific parameters you need – not just the lab as a whole.

  2. 02

    API depth and documentation

    Does the API cover ordering, status tracking, result retrieval, and webhook handling? Is there a sandbox and versioned documentation?

  3. 03

    FHIR R4 support

    FHIR is the relevant interoperability standard for clinical integrations. Clarify which resources are supported (Observation, DiagnosticReport, Specimen).

  4. 04

    Sample-type portfolio

    Capillary blood does not replace every parameter. Make sure the provider supports venous workflows and alternative sample types where medically required.

  5. 05

    Logistics coverage

    EU-wide is the minimum. Clarify tracking, return logistics, and special handling for Switzerland and non-EU destinations.

  6. 06

    White-label depth

    Which elements can be customised: kit box, instructions, packaging, patient portal, result PDF, e-mails? An honest customisation matrix prevents late surprises.

  7. 07

    Data-protection setup

    DPA, hosting location, data separation between provider, lab, and platform. For insurance contexts, also clarify the legal basis.

  8. 08

    References and maturity

    Are there robust live implementations in comparable segments? Time-to-launch, volume, and escalation processes from real projects beat any pitch deck.

Frequently asked

Diagnostics-as-a-Service: FAQ

Eight questions we hear most often in initial conversations with prospective partners.

What is Diagnostics-as-a-Service (DaaS)?
Diagnostics-as-a-Service is an infrastructure model in which laboratory diagnostics – including sampling, logistics, lab analysis, and result delivery – is consumed as an integrated service through a platform. Providers like Probatix bundle white-label test kits, accredited labs, API interfaces, and compliance into one stack. The customer focuses on their product and audience while operational diagnostic complexity is outsourced.

What does DaaS cost?
DaaS is typically priced as a combination of setup fees and usage-based fees per test. Unit cost depends on parameter scope, sample type, white-label effort, and volume. Compared with running your own lab, fixed costs for equipment, facilities, staff, and QMS are eliminated – which makes the model especially economical for mid-range and fluctuating volumes.

How long does integration take?
Initial orders can be placed via the partner portal on the same day. A full API integration with webhook-based result delivery typically takes 2–4 weeks of development time. White-label kits are ship-ready in about two weeks once design and panel selection are approved.

What sample types are supported?
Probatix supports capillary blood (Tasso+, TAP Micro Select), dried blood spot, saliva, urine, and venous blood. Sample type is chosen by the specific parameter, not by user comfort: not every value can be reliably measured from capillary blood. Probatix advises on parameter-to-sample mapping per panel.

Who carries the regulatory responsibility?
As a DaaS platform, Probatix carries responsibility for the parts within its own value creation: kit manufacturing under ISO 13485, logistics, lab orchestration, and platform security under ISO 27001. Accredited partner labs carry the medical-laboratory responsibility under ISO 15189. Customers marketing the kit under their own brand take on the responsibility as placer-on-the-market of that product – the exact split is contractually defined.

Does DaaS work without an in-house engineering team?
Yes. The partner portal is a no-code alternative to the API: ordering, status tracking, and result retrieval work without integration effort. There are also webshop integrations for direct end-user orders. A full API integration is a later optimisation, not a starting block.

Which countries are covered?
Probatix ships kits EU-wide and analyses samples in German ISO 15189-accredited partner labs. Switzerland is served via the Steinhausen branch with adapted data-protection configuration (nDSG/FADP). Non-EU destinations are reviewed case-by-case because logistics and customs requirements vary by country.

How does DaaS differ from a LIS?
A Laboratory Information System (LIS) is the software a lab uses to manage its internal processes – sample intake, instrument integration, validation, reporting. DaaS is the higher-level infrastructure model that provides LIS, sampling, logistics, accredited labs, and an external API as one integrated service. In short: a LIS helps labs run a lab. DaaS helps providers offer diagnostics without running one.

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