Your Strategic Advantage in an Uncertain World
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 US Manufacturing Imperative
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 programs 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 Facility: Fully Integrated IVD CDMO Capabilities
Abingdon Health’s Madison facility isn’t just a manufacturing site; it’s a complete lateral flow immunoassay solution designed for the US market:
- Development Services
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.
- Scale-Up & Technical Transfer
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.
- ISO 13485 Certified Manufacturing
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.
- Regulatory & Performance Evaluation Services
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.
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.
Dual-Facility Strategy: Flexibility Without Compromise
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.
Local Supply Chains, Regional Expertise
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’ve also invested in building relationships with the Wisconsin biotech ecosystem, including the University of Wisconsin-Madison’s research infrastructure. The Madison facility recently received recognition through $49 million in federal funding as part of the Wisconsin Biotech Health Hub initiative, positioning us among the top in vitro diagnostics companies at the centre of one of America’s strongest life science clusters.
Built for Companies That Can’t Afford Delays
We understand the pressure facing diagnostic companies after securing funding or pharma partnerships. Your investor presentations included aggressive timelines. Your board expects execution. Every month of delay erodes competitive advantage and consumes capital without generating revenue.
Our integrated approach directly addresses this challenge. Because lateral flow development, scale-up, manufacturing, and regulatory support operate under one roof, you avoid the coordination delays inherent in managing multiple vendors across different organisations and time zones. Technical questions don’t require scheduling international calls – they get resolved by teams working in adjacent buildings.
This integrated approach compresses concept-to-commercial timelines compared to fragmented CDMO relationships. In markets where category leadership often goes to the first company with a validated product, this advantage can be decisive for long-term success.
Start With a Capabilities Assessment
Every lateral flow project has unique technical requirements, regulatory pathways, and commercial objectives. Before we discuss whether Abingdon Health is the right manufacturing partner for your project, we need to understand what success looks like from your perspective.
Our initial consultation includes:
- Technical feasibility assessment for your specific lateral flow immunoassay development requirements
- Regulatory pathway discussion with realistic timeline estimation for both standard IVD and companion diagnostic assay submissions
- Manufacturing strategy recommendations covering volumes, batch sizes, and packaging approaches
- Transparent cost and timeline projections based on similar projects
No obligations, no pressure – just experienced lateral flow professionals helping you make an informed decision about your development and manufacturing strategy.
Our integrated approach eliminates the coordination challenges of working with multiple vendors, accelerating your path from concept to commercial success.
Abingdon Health is proud of being approachable and values its long-term collaborative partnerships. Dedicated account managers and experienced teams of R&D, tech transfer and manufacturing experts work hard to ensure the delivery of optimum rapid test solutions for the life cycle of product portfolios.
We’re passionate about imparting our knowledge and expertise to help you hit your goals. Contact our team to see how we can take your assay from idea to commercial success.
