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Omega Diagnostics Gp (ODX)


Wednesday 03 November, 2021

Omega Diagnostics Gp

Update on CTDA Regulations

RNS Number : 1360R
Omega Diagnostics Group PLC
03 November 2021

3 November 2021


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


Update on new CTDA Regulations


Omega (AIM: ODX), the specialist medical diagnostics company focused on industry-leading Global Health (CD4 and COVID-19) and Health and Nutrition products, notes the UK Health Security Agency's Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 ("CTDA") which were implemented on 1 November 2021.


The new CTDA Regulations required all suppliers of COVID-19 tests to submit information regarding their products for desktop review prior to 31 October 2021 if they wished their products to remain on sale in the UK after this date. This is a new requirement over and above the requirement for the CE Mark secured for Omega's VISITECT® professional-use COVID-19 Antigen test ("LFT") earlier this year.  


Omega submitted all documentation ahead of the published deadlines and paid the necessary fee, however, in line with the vast majority of available tests on the market Omega's existing LFT has yet to be approved under CTDA.


This new legislation is not expected to cause a delay in the supply of Omega's VISITECT® professional-use COVID-19 Antigen test to DAM Health clinics in the UK under the agreement announced on 1 November 2021. Omega currently remains free to supply  LFTs to DAM Health's clinics throughout Europe and DAM Health are able to distribute Omega's LFT throughout Europe .


The Company will update shareholders as soon as they receive a further update from the UK Health Security Agency.



Omega Diagnostics Group PLC

Colin King, Chief Executive 

via Walbrook PR

Chris Lea, Chief Financial Officer

finnCap Ltd  

Tel: 020 7220 0500

Geoff Nash/Edward Whiley (Corporate Finance)

Alice Lane/ Charlotte Sutcliffe (ECM)

Walbrook PR Limited

Tel: 020 7933 8780 or [email protected]

Paul McManus

Mob: 07980 541 893

Lianne Applegarth

Mob: 07584 391 303

Sam Allen

Mob: 07502 558 258



About Omega Diagnostics Group PLC

Omega manufactures and distributes high quality in-vitro diagnostic products for use in hospitals, clinics, laboratories and healthcare practitioners in over 75 countries and specialise in the areas of health and nutrition and global health.



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