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
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Abingdon Health plc
|
www.abingdonhealth.com/investors/
|
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Chris Yates, Chief Executive Officer
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Via
Walbrook PR
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Chris Hand, Executive Chairman
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Zeus
(Sole Broker and Nominated Adviser)
|
Tel: +44 (0) 20 3829 5000
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Chris Fielding / Alexandra
Campbell-Harris (Corporate Finance)
|
|
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Fraser Marshall (Corporate
Broking)
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Walbrook PR (Media & Investor Relations)
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Tel: +44
(0)20 7933 8780 or abingdon@walbrookpr.com
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Paul McManus / Alice
Woodings
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Mob: +44
(0)7980 541 893 / +44 (0)7407 804 654
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Phillip Marriage
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+44
(0)7867 984 082
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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
