AbC-19TM Rapid Test Update

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AbC-19^TM Rapid Test Update

York, U.K. 29 December 2020:  Abingdon Health plc (AIM: ABDX) ("Abingdon" or "the Company"), a lateral flow diagnostics company providing contract service solutions to a global client base in the healthcare sector and other industries, today provides an update on the AbC-19^TM Rapid Test.

Abingdon continues to liaise with the UK Medicines and Healthcare products Regulatory Agency (MHRA) regarding approval for home use and self-test of the AbC-19^TM Rapid Test for antibodies to the spike protein of the SARS-CoV-2 virus. The Company announced the CE marking of the product for professional use on 30 July 2020. Whilst, as previously disclosed, the Department of Health and Social Care (DHSC) has the option to cancel its Supply of Goods Contract with the Company if a CE mark had not been granted for home use by 25 December 2020, Abingdon continues to work constructively MHRA to try to enable such authorisation.   The Supply of Goods Contract ends on 14^th February 2021.  

Whereas the DHSC has right of first refusal for supplies of the AbC-19^TM Rapid Test, the Company's regulatory department is liaising with regulatory authorities in other jurisdictions around the world to allow use of the product. For example, to allow the continued validity of the current CE marking post Brexit, Abingdon Health, as legal manufacturer via its agent, has successfully registered the AbC-19 Rapid Test with the Maltese Medicines Authority. This means that the CE mark, for professional use, will continue to apply across the European Union after 1 January 2021. The UK-RTC, of which the Company is a member, continues to liaise with customers and regulatory authorities in other international territories. Abingdon's regulatory department is currently working with UK-RTC partners on regulatory approval in a total of 27 territories.

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About Abingdon Health

Established in 2008, Abingdon Health is a lateral flow diagnostics company providing contract service solutions to a global client base in the healthcare sector and other industries. Services offered by the Company to its clients including product development, regulatory support, technology transfer and commercial manufacturing.

The Company has developed and is manufacturing the AbC-19^TM Rapid Test, an antibody test for Covid-19 indicating whether a person is generating IgG antibodies to the spike protein of the SARS-CoV-2 virus. The Company is also working on the transfer of customers' Covid-19 antigen tests to manufacture, and is also manufacturing a component of a rapid PCR (polymerase chain reaction) test.  The Company also produces lateral flow tests covering non-Covid-19 applications in areas such as infectious disease, oncology, animal health and environmental testing.

The Company's main country of operation is the United Kingdom.

For more information visit www.abingdonhealth.com

About UK RTC

The UK-RTC was established by Abingdon Health, Omega Diagnostics, BBI Solutions, CIGA Healthcare and Oxford University.

About AbC19™ Rapid Test 

The AbC-19^TM IgG lateral flow assay is targeted at IgG antibodies to the full spike protein of SARS-CoV-2 (COVID19) to indicate a measure of immune response (aligned with neutralizing antibodies).