Made where your market needs it.
Dual site UK & USA capability
Where a test is made now shapes what it costs, who will buy it and which funding it qualifies for. Relying on one overseas site leaves programmes exposed to changing tariffs, shipping delays and procurement rules that favour domestic supply.
When tariffs reshape cost structures overnight and “Made in America” requirements determine grant eligibility, where you manufacture matters as much as what you manufacture. Abingdon Health’s Madison, Wisconsin facility delivers the integrated lateral flow assay development and lateral flow manufacturing capabilities US diagnostic companies need.
The business environment for in vitro diagnostic medical device manufacturing has fundamentally shifted. Current tariff structures can add 10-40% or more to the cost of imported lateral flow tests, directly impacting your competitive positioning and margins, and US customers (e.g. major retailers) as well as Federal grant programmes and other government funding mechanisms favour US-based manufacturing and supply chains.
Beyond regulatory compliance, US-based lateral flow contract manufacturing delivers operational advantages that offshore alternatives cannot match. Technical discussions happen in real-time, not across time zones. Regulatory questions get resolved through direct interaction with FDA-experienced teams. Supply chain challenges don’t require international shipping coordination. When speed determines market success, proximity matters.
Madison, Wisconsin
In September 2026 we officially opened our new manufacturing hub at University Research Park in Madison, Wisconsin. It builds on the US development and commercial operations we launched there in 2025, and gives US customers onshore development, scale-up and manufacture with one accountable partner.
US-based lateral flow development & manufacturing. FDA-ready facilities, tariff advantages, and integrated IVD CDMO services from concept to commercial launch.
Abingdon Health’s Madison facility isn’t just a manufacturing site; it’s a complete lateral flow immunoassay and IVD solution designed for the US market:
From initial feasibility through design freeze, we specialise in lateral flow test development and design for the user. Our development team works directly with manufacturing engineers to ensure your immunoassay scales efficiently without performance compromises. We support companion diagnostic development for pharmaceutical partners pursuing precision medicine companion diagnostics strategies.
Whether transferring from internal R&D capabilities, academic partnerships, or previous CDMO relationships, we have systematic processes that minimise technical risk and timeline uncertainty. Our approach to technical transfers and project scale up builds confidence at each validation milestone for rapid lateral flow test production.
Commercial-scale lateral flow assay manufacturing with flexible batch sizing, from validation runs through to high-volume manufacturing. Our quality management systems are built for FDA compliance from the foundation up, not retrofitted to meet minimum requirements. As one of the leading lateral flow device manufacturers in the United States, we also understand the critical importance of Good Manufacturing Practice (GMP) in scale up of in vitro diagnostic medical devices.
In-house regulatory expertise for 510(k) submissions, analytical performance validation, stability studies, and clinical trial design. Our team understands FDA expectations because they’ve successfully navigated dozens of submissions for lateral flow immunoassay development and companion diagnostic assay projects.
York, UK
What distinguishes Abingdon Health is our transatlantic manufacturing capability. Our Madison facility operates with identical equipment specifications and standard operating procedures to our York, UK headquarters. This isn’t marketing language; it’s operational reality that delivers tangible business advantages.
Our headquarters at York Biotech Campus is home to our UK development, scale-up and manufacturing teams, with automated production and established supply chains serving customers in Europe and worldwide. Independent analytical and clinical performance testing is available through Abingdon Analytical’s laboratory in Doncaster.
Need US manufacturing for tariff optimisation, customer acceptance or grant compliance? You’re covered. Market conditions shift and European manufacturing becomes strategically advantageous? We can transition production seamlessly. Regulatory requirements change? You have options instead of constraints.
This flexibility in lateral flow test strip manufacturing has proven decisive for customers navigating tariff implementations, regulatory shifts, and supply chain disruptions. When geopolitical or economic conditions change (and they inevitably will), you won’t be locked into a single-country manufacturing strategy with no alternatives.
Our Madison facility prioritises US-based sourcing wherever technically and commercially viable. This approach reduces supply chain vulnerability, supports domestic suppliers, and often improves lead times compared to internationally-dependent alternatives, while optimising lateral flow test manufacturing cost.
We have invested in building relationships with the USA biotech ecosystem, including the University of Wisconsin-Madison’s research infrastructure. Madison is home to the Wisconsin Biohealth Tech Hub and our site there places us among the top in vitro diagnostics companies at the centre of one of America’s strongest life science clusters.
From the Knowledge Centre
Practical guidance from the specialists who deliver this work every day.
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USA Reshoring of Lateral Flow Manufacturing: What’s Driving It & Why It Matters
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