Abingdon Healt. Regulatory News (ABDX)

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF THE UK VERSION OF REGULATION (EU) NO 596/2014 WHICH IS PART OF UK LAW BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018, AS AMENDED ("MAR"). UPON THE PUBLICATION OF THIS ANNOUNCEMENT VIA A REGULATORY INFORMATION SERVICE, THIS INSIDE INFORMATION IS NOW CONSIDERED TO BE IN THE PUBLIC DOMAIN.

Abingdon Health plc

("Abingdon Health" or "the Company")

Contract win: sexually transmitted disease tests

Regulatory and clinical trials contract worth up to US$2million across 2025

York, U.K. 17 December 2024: Abingdon Health plc (AIM: ABDX), a leading international developer, manufacturer and distributor of high quality, rapid diagnostic tests, announces that it has entered into a contract with US-based Find Out From Home LLC ("FOFH") regarding performance evaluation, regulatory services and clinical testing of four sexually transmitted disease ("STD") tests. The contract is worth a total of US$2million and will be performed throughout calendar year 2025. It will begin this month via an initial purchase order for US$350,000.

The FOFH contract is designed to allow the necessary regulatory processes to be completed to allow submission for approval by US FDA and UKCA and CE marking via IVDR. This will enable commercialisation of four lateral flow self-tests for HIV, hepatitis B, hepatitis C and syphilis in the USA, UK and EU. All of these STD tests successfully completed technical transfer to manufacture at Abingdon's York site earlier this year. Other STD tests are also in development.

Abingdon Health will provide clinical trial and performance evaluation study support to allow FOFH to advance these products into clinical trials in H1 2025 with the intention of filing for regulatory submission with the FDA in H2 2025.

The performance evaluation studies will be provided by Abingdon Analytical Ltd, the Company's wholly-owned subsidiary, at its analytical laboratory based in Doncaster, UK.

Chris Yates, CEO of Abingdon Health plc, commented: "We are pleased to announce this contract win, which importantly utilises each limb of our business, including our development, scale-up, manufacturing, regulatory and analytical services, illustrating the breadth of expertise that Abingdon brings to its CDMO customer base. We have worked with FOFH to bring these STD products through technical transfer to this stage of commercialisation. This work brings further value to Abingdon Health via our 17% shareholding in FOFH, which we previously announced through a service-for-equity arrangement."

The global sexually transmitted disease testing market is predicted to grow at a CAGR of ~6% from 2023 to 2035, reaching $145 billion by the end of 2035, up from $95 billion in 2022. Rising cases of STDs in the young adult population, subsequent unsafe sex, and declining awareness of safe sex among young adults are expected to increase transmission of disease.

Enquiries

The person responsible for arranging the release of this announcement on behalf of the Company is Chris Yates, Chief Executive Officer of the Company.

About Abingdon Health plc

Abingdon Health is a leading Medtech contract service provider offering its services to an international customer base.

The Group'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. 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.

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.

For more information visit: www.abingdonhealth.com