Abingdon Healt. Regulatory News (ABDX)

Abingdon Health plc

("Abingdon" or "the Company")

Launch of Semi-Quantitative Accessory to AbC-19™

To help indicate the strength of antibody response and possible immunity

York, U.K. 7 September 2021: Abingdon Health plc (AIM: ABDX), a leading international developer and manufacturer of high quality and effective rapid tests, announces the launch, initially for research use only, of a score-card product available alongside the AbC-19™ rapid test, which provides a semi-quantitative result to indicate the strength of antibody response and possible immunity. This is achieved by the use of a simple line intensity score-card as illustrated here which is available as an accessory to the standard Lateral Flow device ("LFD") for research applications.

The AbC-19™ LFD produces a line in the presence of IgG neutralising antibodies to the spike protein of the SARS-CoV-2 virus as are produced both after vaccination and natural infection. The intensity of the line, which can be seen visually, is proportional to the amount of these IgG neutralising antibodies present in the finger-prick blood sample with higher levels of antibodies producing a stronger test line. The use of the score-card has been referred to in studies, including one from the University of Birmingham, illustrating the use of the AbC-19TM LFD in semi-quantitative format and showing the test line response to be proportional to the amount of antibodies in an international standard1,2.

The use of the score-card accessory alongside AbC-19TM LFD will allow scientific communities to help further understand the presence and strength of IgG neutralising antibodies following infection and/or vaccination, a key indicator of protective immune response and an additional tool to allow stratification of patients in need of booster vaccinations.

Abingdon Health is preparing the CE-marking of this scorecard accessory for the AbC-19TM LFD and ultimately, when the scientific community determines the level of antibodies which infer immunity, has the potential to add a 'cut-off' to the score-card.

Recent research has highlighted that immuno-compromised individuals generate lower levels of antibodies compared with healthier people following two vaccine doses3, and there are variations in vaccine-response between males and females4. A study published on 30 August 2021 highlighted different responses in patient cohorts when comparing the Moderna and Pfizer-BioNTech vaccines5, with one study noting antibody levels start to reduce at around 2-3 months6.

Determining the presence and strength of IgG neutralising antibodies enables governments, individuals and businesses to make more informed decisions about COVID-safety measures and vaccine programme deployment to the most vulnerable. In areas of scarce vaccine supply IgG neutralising antibody testing could be deployed to stratify the population and direct vaccine to those with no or limited immunity to the SARS-CoV-2 virus.

Abingdon Health notes the growing number of administrations such as Hong Kong7 that are now utilising post-vaccine serology testing, in Hong Kong's case with a view to shortening quarantine measures for inbound travellers and the Company believes that the addition of the Semi-Quantitative scorecard accessory will aid further deployment of on-site serology tests such as AbC-19TM. 

Chris Yates, Chief Executive Officer of Abingdon Health, commented: "The launch of the semi-quantitative accessory to AbC-19™ is an important addition to the tools available to researchers as they qualify and measure the antibody level appropriate to infer protective immunity. There is a lot of work underway internationally to set a globally recognised standard threshold and we welcome the establishment of an international standard that will help governments manage their vaccine and booster programmes. Devices such as the AbC-19™ help democratise testing and allow individuals to know their own neutralising antibody status, assess their own risk, and seek appropriate advice when indicated."

References:

1. https://www.abingdonhealth.com/news/abc-19tm-igg-lfd-successfully-used-semi-quantitively-to-monitor-vaccine-responses-to-variant-proteins/

2. https://www.sciencedirect.com/science/article/pii/S0163445321003637

3. https://www.bmj.com/content/374/bmj.n2098

4. https://www.timesofisrael.com/israeli-research-finds-covid-19-antibody-levels-differ-between-men-and-women/

5. https://jamanetwork.com/journals/jama/fullarticle/2783797

6. https://www.ucl.ac.uk/news/2021/jul/vaccine-antibody-levels-start-wane-around-2-3-months

7. https://www.info.gov.hk/gia/general/202108/03/P2021080200985.htm?fontSize=1

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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