How Abingdon Health’s growth in the US will propel the business to new heights
Founded in 2008, Abingdon Health is a leading lateral flow test and MedTech contract service provider offering its services to an international customer base. With its headquarters in the UK, Abingdon Health operates across multiple manufacturing locations, with leased space in the York Biotech Campus and, most recently, in Wisconsin. COO, Mark Jones joins MT to tell us more about the company’s specialisms: “The group’s contract development and manufacturing (CDMO) division offers lateral flow product development, regulatory support, technology transfer and manufacturing services. The turnkey solution is designed for customers looking to develop new assays or transfer existing laboratory-based assays to a lateral flow format. Abingdon Health’s CDMO division has the internal capabilities to take lateral flow projects, in areas including infectious disease, clinical testing, companion diagnostics, animal health and environmental testing, from initial concept through to routine and large-scale manufacturing. 
Suite of services
“Abingdon Health’s regulatory services companies, Compliance Solutions (Life Sciences) and IVDeology, provide a broad range of regulatory services to the in vitro diagnostic and wider medical device industry, to support customers in bringing products to market across various territories including the USA, EU and the UK. Our consultancy services range from design, implementation and maintenance of quality management systems, preparation of technical files for regulatory approvals, and part-time and interim management support, to internal and external auditing, management reviews, presentations, training and mentoring.
“Abingdon Health also owns and operates an e-commerce platform where it sells its Simply Test range of self-tests, which empower consumers to manage their own health and wellbeing. The site offers customers a range of information to support them in making informed decisions on the tests available. In addition, the site provides Abingdon Health’s contract services customers with a potential route to market for self-tests. The range is also sold through international distributors and through other channels in the UK and Ireland, such as pharmacy chains. This includes the world’s first saliva pregnancy test SaliStick – Salignostics, which Abingdon Health helped develop and manufacture through its CDMO services. The company now distributes the product via Boots (under the Boots brand), Tesco, Superdrug and Amazon.”
Two significant acquisitions in 2024 have helped bolster the company’s efforts to provide a complete suite of services that support a customer from product development all the way through to commercialization and beyond. Mark goes on to detail some of the key benefits to the business: “Our new additions to the group, Compliance Solutions (Life Sciences) and IVDeology, provide complementary regulatory services to customers looking to bring products to market in the medical device industry, with services to help customers navigate the various regulatory frameworks of the different territories in which they operate. This completes the ‘one-stop-shop’ for development through to scale up and manufacturing. The pending addition of an analytical services laboratory that provides performance evaluation of products will further complement the suite of services being offered. Along with the regulatory services, this will allow us to make a significant contribution to a product’s regulatory technical file. This will include product stability testing, specificity, sensitivity, assessment of detection limits, interference, cross-reactivity testing and method comparisons. The technical file is a key requirement for regulatory approval by FDA, EU IVDR, UKCA and other regulatory authorities. The analytical laboratory will be able to perform this work for lateral flow assays as well as other in vitro diagnostic tests including enzyme-linked immunosorbent assay (ELISA) and molecular diagnostic tests.”
On top of significant recent acquisitions, the company has also opened a new facility in the US, in Madison, Wisconsin, leasing space in the MGE Innovation Center at University Research Park. The site includes a new lab, production facilities as well as a commercial office. Mark reveals the strategy behind the move: “Our facility in Madison allows increased access and interaction with our increasing US-based customers – about 50 percent of our revenue is generated from customers based in the US. Having a commercial office and laboratory facilities in Madison allows us to develop and manufacture nearer to the customer base and allows us to participate in US grant-funded projects.”
Growth potential
The US is the largest medical device market in the world, making up 40 percent of the global MedTech market and comprising over 6,500 MedTech companies. Abingdon Health has built a portfolio of valued US customers across its various service solutions and believes there is a significant opportunity to expand its US customer base.
Being a CDMO means manufacturing processes can often be more complicated; this makes the impact of smart factory technologies more significant. Mark goes on to explain how Abingdon Health benefits: “We use a mix of inline sensors and data collection techniques to help guide our decision making regarding our production outputs. Being a contract manufacturing company adds its own complexities to our processes as although we produce lateral flow tests, each customer’s product has their own innovations and complexities requiring different solutions. This can range from assembly of different types of plastic devices with different measurable outputs to different reagent vial sizes and seals needing bespoke seal temperatures and dwell times. We use automated equipment as much as we can in our process from dispensing reagents through to the sealing of product into foil devices. Each system utilizes different bespoke measuring systems, from camera-based systems through to sensor probes, to manage output measurements. All our procedures are governed by our ISO13485 approved quality management system and GMP.”
With the positive developments of this year including some key acquisitions and the opening of a new facility, the business is poised to capitalize on its position of strength in a market that is continuing to show significant growth potential. Mark summarizes the company’s ambitions going into the future: “In five years we want to continue to be a leading, globally active and expanding in vitro diagnostics company with a focus on lateral flow and a full CDMO service offering. We endeavor to become the go to company for lateral flow.”