Contract manufacturing for CE marked self-test to monitor antibody status
York, U.K. 23 August 2021: Abingdon Health plc (AIM: ABDX) a leading international developer and manufacturer of high quality and effective rapid tests , announces the launch today of the BioSURE COVID-19 IgG Antibody Self Test. In July 2021, Abingdon announced that it had signed an exclusive manufacturing agreement with BioSure (UK) Limited (“BioSure”), a UK company specialising in the provision of rapid in-vitro diagnostic testing solutions, including self-testing.
This new test, for which BioSure is the legal manufacturer, has been CE marked specifically for self-testing. The test uses a fraction of a drop of finger-prick blood (2.5uL) with results in 20 minutes. This allows individuals to know and monitor their own antibody status pre-vaccination, post-vaccination and following infection with the SARS-CoV-2 virus. It will be particularly useful as populations worldwide continue to be vaccinated to monitor the effectiveness of an individual’s immunity status. This will have utility alongside potential booster vaccinations. Abingdon will be the exclusive worldwide manufacturer for the product.
The product has successfully completed technical transfer to manufacture following a pilot production run and is now in full manufacture at Abingdon’s expanded manufacturing facilities at York and Doncaster under the Company’s ISO13485:2016 quality management system. Technical transfer is the process whereby three or more independent production runs are manufactured, at increasing scale, and validated to illustrate the product is suitable for mass manufacture.
Details of the BioSURE COVID-19 IgG Antibody Self Test can be found here: https://biosuretest.com
Chris Yates, CEO of Abingdon Health, commented: ” We are delighted that BioSure have launched their product and equally happy to be their manufacturing partner. For individuals to be able to monitor their own antibody status at home is a great step in the management of COVID-19. Our own AbC-19 assay will complement this product and we expect the AbC-19 to gain additional utility in semi-quantitative format as recently announced. BioSure also distributes our AbC-19 test which is CE marked for professional use.
“This initiative allows us to build on our long-term collaboration with the BioSure team for whom we manufacture their HIV self-test in the same format as this new test. We are committed to supporting the deployment of these much-needed lateral flow tests to the UK and international markets. This is the first of several products we have previously noted to be going through the technical transfer process with others for COVID antigen and non-COVID applications to follow and which we expect to contribute to contract manufacturing revenue growth.”
Brigette Bard, CEO of BioSure, said: “We are delighted to be continuing the expansion of our product range with Abingdon Health. With our world-first CE marked COVID-19 antibody self-test, we need a world class manufacturing partner for supply into multiple markets. I would personally like to thank all of the team for their incredible work.”
Abingdon Health plc
Chris Yates, Chief Executive Officer
Melanie Ross, Chief Financial Officer
Chris Hand, Non-Executive Chairman
About Abingdon Health
Abingdon Health is a world leading developer and manufacturer of high-quality rapid tests across all industry sectors, including healthcare and COVID-19. Abingdon is the partner of choice for a growing global customer base and takes projects from initial concept through to routine and large-scale manufacturing and has also developed and marketed its own labelled tests.
The Company offers 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 aims to support the increase in need for rapid results across many industries and locations and produces lateral flow tests in areas such as infectious disease, clinical testing including companion diagnostics, animal health and environmental testing. Faster access to results allows for rapid decision making, targeted intervention and can support better outcomes. This ability has a significant role to play in improving life across the world. To support this aim Abingdon Health has also developed AppDx®, a customisable image capturing technology that transforms a smartphone into a self-sufficient, standalone lateral-flow reader.
Founded in 2008, Abingdon Health is headquartered in York, England.
For more information visit: www.abingdonhealth.com
About BioSure (UK) Limited
BioSure (UK) Limited are the manufacturers of the first CE marked HIV Self-Test for personal use giving results in minutes. Since launching in 2015, the BioSURE HIV Self Test has helped people throughout the UK and the world, to #knowyourstatus. Since the beginning of the COVID-19 pandemic, BioSure have pivoted their expertise and now have a range of UK developed and manufactured COVID-19 tests, which are available for professional use in the UK and international markets.
Since launching the world’s first approved blood-based HIV self-test, BioSure has worked with governments, communities, and individuals across the world, generating conversations, giving people a choice of being able to test themselves and know their own status on their own terms and just as importantly, giving people the confidence to make informed choices.
For more information visit: www.biosure.co.uk
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