€2m contract win for companion diagnostic test

Abingdon Health plc

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

€2m contract win for companion diagnostic test

Full CDMO service contract covering development, scale-up, technical transfer, manufacture and full regulatory approval support

York, U.K. 12 June 2025: Abingdon Health plc (AIM: ABDX), a leading international developer, manufacturer and distributor of high quality and effective rapid tests, announces a new c.€2 million contract win with a leading European biotech company for the continued development and regulatory approval of a companion diagnostic lateral flow point of care test. Most of this project and associated revenue will fall into FY26.

Following the successful completion of the feasibility stage of the development process, the Company has signed a Master Service Agreement ("MSA") which covers the optimisation, scale-up, technical transfer and manufacturing of the completed product alongside comprehensive regulatory support.

The provision of regulatory approval support includes the building of the technical file, including providing performance evaluation studies and clinical trial management, preparing regulatory submission, including for the USA, and leading the regulatory submission process. The project is expected to take approximately 24 months.

This contract win underlines the strength of Abingdon Health's contract development and manufacturing organisation ("CDMO") offering which provides customers with comprehensive support to take an "idea through to commercial success". The recent acquisitions of IVDeology and CS Lifesciences, combined with the launch of Abingdon Analytical, has allowed Abingdon to complement its existing lateral flow development and manufacturing capabilities with a full performance evaluation, quality and regulatory service offering supported by its 45-strong regulatory team. The significant benefits of having one outsourced partner covering all aspects of product development is resonating well with customers as evidenced by this new contract win.

Abingdon Health's brochure outlines in further the comprehensive support the Company can now provide to its international customers.

Dr Chris Hand, Executive Chairman of Abingdon Health plc, commented: "We are delighted to announce this new contract win which underlines the strength of our fully integrated CDMO service offering. Our approach is to offer customers a complete diagnostic solution; from concept to commercial success and we are pleased to see this resonating well with customers as evidenced by this contract win. Our expertise in companion diagnostics product development is increasingly a major differentiator. 

"In this contract we are fully managing the companion diagnostic development process alongside our client's therapeutic drug development process which adds significant complexity. Our expertise across both the development and regulatory aspects of companion diagnostic product development gives the customer piece of mind that the overall project will be managed effectively under one roof."

Enquiries:

About Abingdon Health plc

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

The Company's CDMO division 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's CDMO division 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 and large-scale manufacturing; from "idea to commercial success".

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. Its 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. The Company's subsidiary, Abingdon Analytical Ltd, offers analytical testing and performance evaluation to generate the required technical and data for regulatory approval.

Abingdon Health's Abingdon Simply Test range of self-tests is an e-commerce platform that offers a range of self-tests to empowers consumers to manage their own health and wellbeing. The Abingdon Simply Test e-commerce site offers consumers a range of information to support them in making informed decisions on the tests available. In addition, the site provides Abingdon's contract services customers with a potential route to market for self-tests. The Abingdon Simply Test range is also sold through international distributors and through other channels in the UK and Ireland, such as pharmacy chains.

Founded in 2008, Abingdon Health is headquartered in York, England with additional facilities in Doncaster, England and Madison, WI, USA.

For more information visit: www.abingdonhealth.com