Omega Diagnostics Group PLC Statement re. Media Comment (9486B)
15 June 2021 - 7:49PM
UK Regulatory
TIDMODX
RNS Number : 9486B
Omega Diagnostics Group PLC
15 June 2021
OMEGA DIAGNOSTICS GROUP PLC
("Omega" or the "Company" or the "Group")
Statement re. Media Comment
Omega (AIM: ODX), the medical diagnostics company focused on
CD4, infectious diseases and food intolerance, notes the recent
media comment that Mologic Ltd have requested for Porton Down to
evaluate their lateral flow antigen test with an independent party
observing.
This process has no implications on the UK Government
manufacturing contract that Omega has in place with the Department
of Health and Social Care ("DHSC"). Under that contract Omega will
provide manufacturing capacity for COVID-19 lateral flow antigen
tests utilising the key pieces of manufacturing equipment loaned by
the UK Government for that purpose and Omega will manufacture
whichever test is approved for use by the DHSC. As clarified on 7
June 2021 the ability to supply tests that are produced within the
UK remains a key priority for the DHSC and to that end the DHSC
have facilitated initial commercial discussions between Omega and a
number of companies with lateral flow antigen tests to potentially
provide UK manufacturing services.
As already announced on 8 June 2021 Omega is in the process of
seeking CE marking of its VISITECT(R) COVID-19 Antigen test, as a
self-test. Final preparations for a submission to the U.S. Food and
Drug Administration (FDA) requesting Emergency Use Authorization
(EUA) for this test is also underway.
Recently published study data confirms that Mologic's lateral
flow antigen test, being commercialised by Omega as the VISITECT(R)
COVID-19 Antigen test , demonstrates high diagnostic accuracy
(specificity and sensitivity) fulfilling WHO target accuracy with a
high sensitivity (93.2%-98.4%) detecting individuals with high
viral load infections (Ct<20 and Ct<25). The test has also
been independently verified in a 665-person study in Germany by
FIND a global not-for-profit foundation and a WHO collaborating
centre. The test was shown to demonstrate best-in-class performance
with 100% specificity and 96.4% sensitivity (Cycle threshold
<25) compared with laboratory PCR testing.
Further details of the study and the FIND report can be seen
using the links below:
https://www.londonstockexchange.com/news-article/ODX/positive-data-for-covid-19-antigen-test/14998113
https://www.londonstockexchange.com/news-article/ODX/positive-data-for-mologic-covid-19-antigen-test/14963499
Contacts:
Omega Diagnostics Group PLC www.omegadiagnostics.com
Colin King, Chief Executive via Walbrook PR
Kieron Harbinson, Group Finance
Director
finnCap Ltd Tel: 020 7220 0500
Geoff Nash/Edward Whiley (Corporate
Finance)
Alice Lane (ECM)
Walbrook PR Limited Tel: 020 7933 8780 or omega@walbrookpr.com
Paul McManus Mob: 07980 541 893
Lianne Cawthorne Mob: 07584 391 303
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END
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