One diagnostics partner. Two manufacturing hubs. Every stage covered.
Abingdon Health is a leading international lateral flow and IVD CRO and CDMO focused on supporting our customers on the path to commercialisation.
Our Diagnostics division brings nearly two decades of lateral flow expertise to the formats customers now ask for: single-strip and multiplex lateral flow, molecular and hybrid tests, biosensors, and results read by a device or supported by AI. Scientific development, manufacturing and regulatory teams in York, UK and Madison, Wisconsin work under a single QMS using unified methodologies, so your rapid diagnostic is designed for manufacture, regulatory approval and market access, not just to work in the lab as a prototype.
Rapid in vitro diagnostics, from lateral flow to molecular and reader-based tests, are supporting the move away from laboratory methods towards point of care testing; thereby supporting faster decision-making and treatment.
Most delays in diagnostics are not caused by the science. They come from early decisions made in isolation, which only become a problem at scale-up, regulatory submission or market launch.
| Where programmes stall | What it costs | How we prevent it |
|---|---|---|
| Assay designed for the bench, not the production line | Redesign at transfer, meaning months of delay and re-work costs | Design for manufacture from the first feasibility study, using GMP methods |
| Development, regulatory and manufacturing split across multiple vendors | Rework, duplicated or inconsistent documentation and unclear ownership | One programme team, one quality system and supply chain control, from concept to market access |
| Regulatory strategy left until development is finished | Missing evidence, reviewer queries and repeat studies | Regulatory specialists involved from day one, with evidence planned around your intended use and target markets |
| Single-site supply in a shifting trade environment | Tariff exposure, supply interruption and lost tenders | Matched manufacturing in York, UK and Madison, USA |
| Readers, apps or AI added after the assay design is fixed | Changes to the strip, the reader or both | Digital features planned in the same development programme as the assay |
At Abingdon Health, we provide end-to-end diagnostics and lateral flow development and manufacturing solutions under one roof. Our integrated approach streamlines your journey from concept to commercialisation, eliminating the inefficiencies of managing multiple vendors. Saving you time and money and accelerating the path to market for your innovative product.
Our expert scientists transform your biomarker into a precise, reliable lateral flow assay. Using cutting-edge technology and decades of collective experience, we optimise your test for sensitivity, specificity, and usability. Working collaboratively with your team, we create bespoke solutions tailored to your exact requirements.
Seamlessly transition from development to large-scale production without changing facilities. Our state-of-the-art manufacturing capabilities ensure consistent quality through validated processes. We maintain rigorous control across all production stages, from raw material handling to final packaging.
Alongside your development, we navigate on your behalf the complex regulatory landscape via our team of over 45 regulatory professionals. We provide comprehensive documentation support and guidance through CE marking, FDA approval, and other global regulatory pathways covering over 90 territories. Our quality management system ensures your products meet the highest standards worldwide.
Validate your product’s performance with our meticulous validation and verification services. Our dedicated teams conduct thorough testing to confirm reliability and reproducibility, providing the evidence required for regulatory submission and building market confidence. Analytical and clinical performance evaluation studies can be run independently by our sister company, Abingdon Analytical, in its ISO/IEC 17025 accredited laboratory in Doncaster, UK.
By integrating IVD design & development, scale up, regulatory consultancy and manufacturing capabilities under one roof, we create parallel workstreams that accelerate your timeline while maintaining exceptional quality. This cohesive approach eliminates communication gaps, reduces transfer delays, and optimises resource allocation, ultimately saving you time and money while expediting your path to market access.
Abingdon Health offers a comprehensive range of diagnostics and lateral flow CRO, CDMO and regulatory contract services. In essence, we provide our customers with a comprehensive lateral flow service solution to take their projects from idea to commercial success. We can take tests from concept through to routine lateral flow test manufacture or transfer in standard operating procedures and scale-up production quickly and accurately.
Abingdon Health is certified to ISO 9001 and ISO 13485, and is compliant to FDA 21 CFR 820 (QMSR) and Good Manufacturing Practice (GMP). Abingdon Health also meets regulatory requirements of UK MDR 2002, the IVDD 98/79/EC and the IVDR 2017/746. In addition, our facilities have an establishment registration with the FDA.
Assay development, scale-up, technical transfer, manufacturing and packaging for lateral flow and wider IVD formats, including companion diagnostics.
Molecular and hybrid lateral flow, biosensors, novel labels and multiplex formats, taken from feasibility to an IVD product that can be made at volume.
IVD regulatory strategy, submissions and performance evaluation for the US, EU, UK and international markets, built into development rather than added at the end.
Digital readers, smartphone apps and AI-assisted interpretation, designed alongside your assay with a clear regulatory route.
Development and manufacture in York, UK and Madison, Wisconsin, where our new US manufacturing hub is now open.
Many years of developing lateral flow assays for clients and having launched our own products, means we recognise the pressures of developing new rapid tests. Through tried and tested methods, our assay development scientists work alongside in-house regulatory experts and a network of quality suppliers to take tests from R&D into routine manufacture.
Every in vitro diagnostics 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:
No obligations, no pressure. Just experienced diagnostics professionals helping you make an informed decision about your development and manufacturing strategy.
Abingdon Health is proud of being approachable and values its long-term collaborative partnerships. Dedicated, experienced teams of R&D, technical transfer and manufacturing experts work alongside programme management teams to ensure the delivery of optimum rapid test solutions for the life cycle of product portfolios.
Our facilities
Three sites under one quality system, supporting clients across the UK, Europe and North America.
Our headquarters on the York Biotech Campus, with assay development laboratories, GMP cleanroom manufacturing, quality control and warehousing.
Home to Abingdon Analytical: accredited laboratory testing, stability studies, method validation and performance evaluation for IVDs and medical devices.
Our US base provides local client engagement, technical support and project management including development through to manufacturing on site, with direct links to our York manufacturing facility.
From the Knowledge Centre
Practical guidance from the specialists who deliver this work every day.
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Eco-Housings Brochure
Compostable, seaweed-based housings for lateral flow tests: equivalent performance on the same production lines, with no plastic.
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Abingdon Health is proud to partner with VenomAid Diagnostics in developing a rapid snakebite diagnostic to bring life-saving care to neglected populations worldwide.
We’re passionate about sharing 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.