Proven at home. Ready for Europe.
Gateway Diagnostics takes clinically proven diagnostic tests from China and the United States through European regulation and into routine clinical use across Europe, the Middle East and Africa.
Two starting points, one route into Europe.
Companies arrive with different approvals, different expectations and different gaps. We have launched products into Europe from both.
From China
For NMPA-approved tests with strong domestic adoption and no European presence yet.
- Five years running the European affiliate of a Chinese IVD group, from first hire to Sysmex Europe distribution
- NMPA clinical data mapped against IVDR performance evaluation requirements
- Cold-chain import from China and temperature-controlled storage in Europe
- Proposal materials in Simplified and Traditional Chinese
From the United States
For FDA-cleared tests whose owners have put Europe on hold because IVDR looks too slow or too costly.
- European launches for US diagnostics companies, including a heart failure assay taken to 12 countries
- FDA submissions reviewed for what can carry over to IVDR, and what cannot
- EU and UK market access without setting up your own European entity
- A staged plan that fits a venture-backed budget and board
Building a diagnostics company? Skip the expensive lessons.
Most IVD start-ups make the same handful of mistakes, and most of them are cheap to avoid if you see them coming. We have seen them from the inside, and we bring a network of specialists who have solved them before, available when you need them rather than as permanent headcount.
Sensor and assay technology
Specialists in biosensors and assay design who can pressure-test your platform before you lock it down.
Scale-up manufacturing
People who have taken diagnostics from pilot runs to volume production, including yield, cost of goods and supplier qualification.
Regulatory and quality
IVDR, FDA, MHRA and ISO 13485 experience, so your quality system and technical file are built right the first time.
International markets
Commercial experts across Europe, the Middle East, Africa and Asia, with established distributor and clinician relationships.
Intended use and claims fixed late in development, triggering an unexpected IVDR class and evidence burden.
Intended use and claims defined early, with regulatory and commercial input from day one.
ISO 13485 and technical documentation left until the product is ready to launch.
Quality system and documentation built alongside development, so certification is not a rebuild.
Clinical studies that satisfy a journal but not a notified body, guideline committee or payer.
Evidence plans designed around what regulators, clinicians and payers actually need.
Pricing that leaves no room for distributor margin, registration or service costs.
Cost of goods and pricing modelled through the whole channel before launch.
Exclusive distributors signed early, with no targets, tying up key markets for years.
Partners chosen for focus and fit, with performance targets and clear exit terms.
Launching in every market at once and spreading a small team and budget too thin.
A lead-market plan that builds reference sites and data before expanding.
Launch readiness review
A focused review of your regulatory, evidence, pricing and channel plans before you commit the budget.
Advisory and interim leadership
Board or advisory support, or hands-on commercial leadership while you build your own team.
For investors
Commercial due diligence on diagnostics opportunities, from market access to realistic launch timelines.
We work with a few companies, deliberately.
Every product we take on shares our existing pathology, oncology and hospital laboratory channels. That keeps it a core line for us, not one of hundreds in a distributor's catalogue.
A strong fit
- IVD companies from China and the US with NMPA or FDA approval
- Molecular and high-value tests with real clinical differentiation
- Oncology and cardiology, where we have launched before
- Proven in their home market, with no European presence yet
- Early-stage IVD companies planning their route to market
Not what we do
- Commodity rapid tests and lateral flow
- Me-too products competing on price alone
- Companies already established in Europe
Three stages, each with a decision point.
You only commit to the next stage when the evidence supports it. A clear answer early costs far less than a stalled notified body submission or an idle distributor.
Assess
IVDR classification, a gap analysis of your technical file and clinical data, and a market and reimbursement review for target countries.
Launch
Notified body route, EU authorised representative, import and cold-chain logistics, post-market surveillance, key opinion leaders and first reference sites.
Scale
Direct roll-out, a single major distribution partner or specialist distributors, whichever fits the product. Supported by publications and ongoing clinical evidence.
The Gateway model is already working.
Three recent projects show the same approach applied to three different starting points. The skills behind them were learned over thirty years inside diagnostics companies, large and small.
Rich Hughes
Rich has built European launches from a standing start for US and Asian diagnostics companies, covering regulatory, distribution, key opinion leaders and sales. He founded Gateway Diagnostics in 2017 to do that for non-EU IVD companies, and since 2021 has run the European affiliate for a Chinese molecular oncology company.
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China to Europe
Cerca Biotech
Full European affiliate for a Chinese IVD group, built from the first hire: team, quality system, clinical and regulatory affairs, and distribution for MammaTyper®, a molecular breast cancer subtyping assay.
Sysmex Europe distribution, specialist partners in further markets, 30+ clinical studies and peer-reviewed publications, on under $1M a year.
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United States to Europe
Entegrion
European launch planning for a US diagnostics company: market assessment, regulatory route and channel strategy.
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Taiwan to EMEA
iXensor
Market intelligence and distribution channel set-up for an Asia-Pacific point-of-care testing company entering EMEA.
Where the trade was learned
- AlereEuropean launch of rapid cardiac triage and coagulation tests$500k to $30M in three years
- Critical DiagnosticsBuilt the EMEA sales and distribution network from scratch for the Presage® ST2 heart failure assay, and set up the EU headquarters12 countries, 25% growth in year two
- MicroviskCoagMax® point-of-care INR launch plan and European distributionCore technology acquisition
- Philips Handheld DiagnosticsEMEA distributor channel for point-of-care troponin75% of EMEA placements
Companies we have worked with
Tell us about your test.
A 30-minute call is enough to tell whether your product fits, and what a Stage 1 assessment would involve. Our materials are available in English and Chinese.
Email Richrich@gatewayscs.com
Based in Bristol, UK. Working across Europe, the Middle East, Africa and China.