Share Name Share Symbol Market Type Share ISIN Share Description
Omega Diagnostics Group Plc LSE:ODX London Ordinary Share GB00B1VCP282 ORD 4P
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  -1.50 -5.66% 25.00 24.00 26.00 26.75 24.25 26.25 5,069,727 15:58:44
Industry Sector Turnover (m) Profit (m) EPS - Basic PE Ratio Market Cap (m)
Health Care Equipment & Services 8.7 -35.4 -1.2 - 46

Omega Diagnostics Group PLC Update on CTDA Regulations

03/11/2021 7:00am

UK Regulatory (RNS & others)

Omega Diagnostics (LSE:ODX)
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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(R) 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(R) 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                                     www.omegadx.com 
  Colin King, Chief Executive                                     via Walbrook PR 
  Chris Lea, Chief Financial 
  finnCap Ltd                                                  Tel: 020 7220 0500 
  Geoff Nash/Edward Whiley (Corporate 
  Alice Lane/ Charlotte Sutcliffe 
  Walbrook PR Limited                  Tel: 020 7933 8780 or omega@walbrookpr.com 
  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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(END) Dow Jones Newswires

November 03, 2021 03:00 ET (07:00 GMT)

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