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Omega Diagnostics Gp (ODX)

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Friday 02 July, 2021

Omega Diagnostics Gp

FDA submission for Emergency Use Authorization

RNS Number : 9308D
Omega Diagnostics Group PLC
02 July 2021
 

OMEGA DIAGNOSTICS GROUP PLC

("Omega" or the "Company" or the "Group")

 

FDA submission for Emergency Use Authorization

 

Omega (AIM: ODX), the medical diagnostics company focused on CD4, infectious diseases and food intolerance, announces that following completion of the of US performance studies, its technology partner, Mologic Ltd ("Mologic") has filed its 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® brand and Global Access Diagnostics (GAD) brand. The Company will provide a further update on the process in due course.

 

Colin King, CEO of Omega, commented: 

"We are very pleased that the regulatory process to make our VISITECT® COVID-19 Antigen test available in the US professional use is progressing well. We believe we have a high-quality, high-performance product with significant global appeal and the US market, due to both its size and high barriers to entry, would be a very attractive commercial market for our product."

 

  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 [email protected]

Paul McManus

Mob: 07980 541 893

Lianne Cawthorne

Mob: 07584 391 303

 

 

 

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