Abingdon Health PLC AbC-19TM Rapid Test Update (9380J)
29 Dicembre 2020 - 8:00AM
UK Regulatory
TIDMABDX TIDMODX
RNS Number : 9380J
Abingdon Health PLC
29 December 2020
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN
PART, DIRECTLY OR INDIRECTLY, IN OR INTO OR FROM THE UNITED STATES,
AUSTRALIA, CANADA, JAPAN OR SOUTH AFRICA OR ANY JURISDICTION WHERE
IT IS UNLAWFUL TO DISTRIBUTE THIS ANNOUNCEMENT
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.
Enquiries:
Abingdon Heath plc
Chris Yates Chief Executive Officer Via Consilium
Chris Hand Non-Executive Chairman
Scott Page Finance Director
N+1 Singer Sole Broker and NOMAD Tel: +44 (0) 20 7496 3000
Shaun Dobson, Pete
Steel and Alex Bond
(Corporate Finance)
Tom Salvesen (Corporate
Broking)
Consilium Financial PR Tel: +44 (0) 7720 088 468
Matthew Neal abingdonhealth@consilium-comms.com
Mary-Jane Elliott
Lindsey Neville
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(TM) 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).
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
UPDFVLLLBLLZFBZ
(END) Dow Jones Newswires
December 29, 2020 02:00 ET (07:00 GMT)
Grafico Azioni Omega Diagnostics (LSE:ODX)
Storico
Da Mar 2024 a Apr 2024
Grafico Azioni Omega Diagnostics (LSE:ODX)
Storico
Da Apr 2023 a Apr 2024