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: [phone]
Geoff Nash/Edward Whiley (Corporate Finance)
Alice Lane (ECM)
Walbrook PR Limited	Tel: [phone] or [e-mail]
Paul McManus	Mob: [phone]
Lianne Cawthorne	Mob: [phone]

 

END

 

 

NRABLGDRISGDGBB