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
Abingdon Health plc
www.abingdonhealth.com/investors/
Chris Yates, Chief Executive Officer
Via Walbrook PR
