Omega Diagnostics Group PLC Regulatory progress for VISITECT(R) COVID-19 test (0850B)
June 08 2021 - 1:00AM
UK Regulatory
TIDMODX
RNS Number : 0850B
Omega Diagnostics Group PLC
08 June 2021
OMEGA DIAGNOSTICS GROUP PLC
("Omega" or the "Company" or the "Group")
Regulatory progress for VISITECT(R) COVID-19 Antigen test
Omega (AIM: ODX), the medical diagnostics company focused on
CD4, infectious diseases and food intolerance, provides the
following update on VISITECT(R) COVID-19 Antigen test regulatory
approvals.
Regulatory approvals
Omega announces that it has begun the process of engagement with
its European Notified Body seeking CE marking of the VISITECT(R)
COVID-19 Antigen test, a rapid point-of-care diagnostic test for
the detection of active COVID-19 infections as a self-test. The
Company is agreeing the protocols required for utilisation studies
and will update shareholders as this process progresses. The test
is already CE marked for professional-use and the Company is
targeting approval by the end of July to allow the test to be sold
in Europe for home-use as well. As the global market for Antigen
testing develops the Company believes self-test approval will be a
key product differentiator, as has already been seen in the UK.
The Company also announces that its technology partner, Mologic
Ltd ("Mologic") has successfully completed the necessary
performance studies required for regulatory approval in the US and
is now in the final stages of preparing a submission to the U.S.
Food and Drug Administration (FDA) requesting Emergency Use
Authorization (EUA) for its rapid point-of-care COVID-19 antigen
test, for use under both the Omega's VISITECT(R) brand and Global
Access Diagnostics brand.
Colin King, CEO of Omega, commented:
"I am pleased with the progress we are making to gain regulatory
approval, both for our VISITECT self-test product and for US
professional use. Both routes offer potentially significant
opportunities as we believe we have a high quality product with
global appeal."
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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