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RNS Number : 4614M Abingdon Health PLC 12 June 2025
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
(https://www.abingdonhealth.com/wp-content/uploads/2025/06/Abingdon-Health-Group-Leaflet-JUN2025.pdf)
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:
Abingdon Health plc www.abingdonhealth.com/investors/ (http://www.abingdonhealth.com/investors/)
Chris Hand, Executive Chairman Via Walbrook PR
Tom Hayes, CFO
Zeus (Sole Broker and Nominated Adviser) Tel: +44 (0)20 3829 5000
Antonio Bossi / 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
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
(https://urldefense.proofpoint.com/v2/url?u=https-3A__www.abingdonhealth.com_services_&d=DwMFAg&c=euGZstcaTDllvimEN8b7jXrwqOf-v5A_CdpgnVfiiMM&r=b40MoFA_Q_fdsT77LXB5t3JFUZjlmpd2MVbmgvoBIOo&m=5rmPWmSeAYNtvo-wVGL_4V7p0wZ2qRPhbqDj6E6FHnhVakMVyzvk7wZG1jS6vI4P&s=HA76POaNPDBWSuSNqpvm6h6sTVAmwDfGPxyLLvvNBHg&e=)
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://urldefense.proofpoint.com/v2/url?u=https-3A__cslifesciences.com&d=DwMFAg&c=euGZstcaTDllvimEN8b7jXrwqOf-v5A_CdpgnVfiiMM&r=b40MoFA_Q_fdsT77LXB5t3JFUZjlmpd2MVbmgvoBIOo&m=5rmPWmSeAYNtvo-wVGL_4V7p0wZ2qRPhbqDj6E6FHnhVakMVyzvk7wZG1jS6vI4P&s=PvbE1xuJgNrAaK0I9QSrYjO3acai4ITHsbheoH-Cavc&e=)
and IVDeology
(https://urldefense.proofpoint.com/v2/url?u=https-3A__www.ivdeology.co.uk&d=DwMFAg&c=euGZstcaTDllvimEN8b7jXrwqOf-v5A_CdpgnVfiiMM&r=b40MoFA_Q_fdsT77LXB5t3JFUZjlmpd2MVbmgvoBIOo&m=5rmPWmSeAYNtvo-wVGL_4V7p0wZ2qRPhbqDj6E6FHnhVakMVyzvk7wZG1jS6vI4P&s=mbRruUP_NEre93fFYpNkBweGVcmSCnXpjUyMQmUx1yI&e=)
, 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
(https://urldefense.proofpoint.com/v2/url?u=http-3A__www.abingdonsimplytest.com&d=DwMFAg&c=euGZstcaTDllvimEN8b7jXrwqOf-v5A_CdpgnVfiiMM&r=b40MoFA_Q_fdsT77LXB5t3JFUZjlmpd2MVbmgvoBIOo&m=5rmPWmSeAYNtvo-wVGL_4V7p0wZ2qRPhbqDj6E6FHnhVakMVyzvk7wZG1jS6vI4P&s=71SLyhJsm1hJqJvXuK0jPc4-fr_IZIW_VOOfo4sJwQw&e=)
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
(https://urldefense.proofpoint.com/v2/url?u=http-3A__www.abingdonhealth.com_&d=DwMFAg&c=euGZstcaTDllvimEN8b7jXrwqOf-v5A_CdpgnVfiiMM&r=b40MoFA_Q_fdsT77LXB5t3JFUZjlmpd2MVbmgvoBIOo&m=5rmPWmSeAYNtvo-wVGL_4V7p0wZ2qRPhbqDj6E6FHnhVakMVyzvk7wZG1jS6vI4P&s=Cd1Yy0EoU5vx33xedoTE3bCKbljgDOIRD8ol-bb59BM&e=)
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