Abingdon Healt. Regulatory News (ABDX)

Abingdon Health plc

("Abingdon Health", the "Group" or the "Company")

US CDMO Operations Update

Five projects underway since opening of Abingdon Health USA Inc facilities in April 2025

Phase two expansion plans for high throughput manufacturing capacity progressing well

York, U.K. 1 September 2025: Abingdon Health plc (AIM: ABDX) a leading international developer, manufacturer and regulatory services provider for rapid diagnostic tests and med-tech, provides an update on the successful establishment of contract development and manufacturing organisation ("CDMO") activities at its Madison, Wisconsin facilities in the US with five new development projects signed and underway.

Since April 2025, when its Madison facilities began operations, the Company has worked with many customers and potential customers wanting US-based CDMO services for lateral flow tests. Project details are confidential, but the wide-ranging areas currently in progress via contract development projects with US customers include:

· Development of a duplex lateral flow to quantitatively measure the concentrations of a pharmaceutical product and its metabolite.

· Development of a lateral flow veterinary product for use initially in canine samples.

· Feasibility work with a leading US university to evaluate novel nanoparticles for use in a lateral flow format.

· Development of a lateral flow test for infectious disease initially in bovine animals.

· Development of a test for an infectious agent in animals and humans, with a spin-out of leading US university.

All of these projects are being run from the Madison facility with support from colleagues at the Company's UK facilities.

These contract wins underline the importance of Abingdon Health's expansion of its CDMO offering in the US, extending its global reach to current and new US-based clients. Abingdon Health's value proposition, which provides customers with comprehensive support to take an "idea through to commercial success", is resonating well in the USA.

Expansion of US facility

Abingdon Health also announces that the second phase of its US facility expansion in Madison is underway with plans commenced for the installation of high-throughput manufacturing to enable the seamless transition of projects from development into manufacturing. The manufacturing equipment will mirror Abingdon Health's UK operation to allow customers to manufacture under the same operating conditions and quality management system in either the USA, the UK, or both. This provides customers with unrivalled geographic optionality during a period of tariff and supply chain uncertainty and provides US customers with the confidence that products "developed in the USA" by the Company's highly skilled CDMO team can also be "made in the USA".

Details of Abingdon Health's comprehensive CDMO capabilities can be found in the brochure here:

https://www.abingdonhealth.com/wp-content/uploads/2025/06/Abingdon-Health-Group-Leaflet-JUN2025.pdf

Dr Chris Hand, Executive Chairman of Abingdon Health plc, commented:

"These contract awards validate our decision to expand our CDMO operations into the USA and we anticipate further expansion in Madison, Wisconsin, as projects and products move through the development cycle. It is pleasing to see our US customers recognise the value of our comprehensive CDMO platform. We deliver end-to-end diagnostic solutions from initial concept through to market launch, and these contract wins illustrate strong confidence in our approach from US-based clients".

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About Abingdon Health plc

Abingdon Health Group is a leading med-tech contract service provider offering its services to an international customer base.

The Group's CDMO expertise offers lateral flow product development, regulatory support, technology transfer and manufacturing services for customers looking to develop new assays or transfer existing laboratory-based assays to a lateral flow format. Abingdon Health has the internal capabilities to take lateral flow projects, in areas such as infectious disease and clinical testing, including companion diagnostics, animal health and environmental testing, from initial concept through to routine manufacturing; from "idea to commercial success". Abingdon Analytical Ltd offers performance evaluation for lateral flow and other in vitro diagnostic assays from its Doncaster laboratory. 

Abingdon'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 a range of 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, part-time and interim management support, auditing both internal and external, management reviews and presentations, training and mentoring.

Founded in 2008, Abingdon Health is headquartered in York, England with laboratories in Doncaster, England and laboratories and commercial offices in Madison, Wisconsin, USA.

Abingdon Health's brochure outlines the comprehensive support the Group can now provide to its international customers. For more information visit: www.abingdonhealth.com.