REG - Abingdon Health PLC - Contract win: sexually transmitted disease tests

Abingdon HealthAnnouncement

17/12/2024 07:00

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RNS Number : 3086Q  Abingdon Health PLC  17 December 2024

 

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF
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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
(https://www.londonstockexchange.com/news-article/ABDX/design-freeze-completion-strategic-partnership/16392170)
through a service-for-equity arrangement."

The global sexually transmitted disease testing market is predicted to grow
(https://finance.yahoo.com/news/sexually-transmitted-disease-testing-market-110000522.html?guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAABjeZ-mK51eQuxMK_1Tm68JXgL7IlSd_i30OebNcu5KdOehrF9j2ekqdeST8v35CPnp_VmeS7odaieELvclDg5R_hL3jy2dTRW_5coz14IuIfr1Mg51WP1m_5ab7gJ1eRSdWV0JuZajyegeHqtGhHC7p9VDVIM0rz0IGiKEN3FAk&guccounter=2)
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/ (http://www.abingdonhealth.com/investors/)
 Chris Yates, Chief Executive Officer                                            Via Walbrook PR
 Chris Hand, Executive Chairman

 Zeus (Sole Broker and Nominated Adviser)                                          Tel: +44 (0) 20 3829 5000
 Chris Fielding / Alexandra Campbell-Harris (Corporate Finance)
 Fraser Marshall (Corporate Broking)

 Walbrook PR (Media & Investor Relations)      Tel: +44 (0)20 7933 8780 or abingdon@walbrookpr.com
                                               (mailto:abingdon@walbrookpr.com)
 Paul McManus / Alice Woodings                 Mob: +44 (0)7980 541 893 / +44 (0)7407 804 654
 Phillip Marriage                              +44 (0)7867 984 082

 

 

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 (https://www.abingdonhealth.com/services/) 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)
(https://cslifesciences.com) and IVDeology (https://www.ivdeology.co.uk) ,
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
(http://www.abingdonsimplytest.com) 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
(http://www.abingdonhealth.com/)

 

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