We could not find any results for:
Make sure your spelling is correct or try broadening your search.
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 | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 2.20 | 2.00 | 2.40 | 0.00 | 01:00:00 |
Industry Sector | Turnover | Profit | EPS - Basic | PE Ratio | Market Cap |
---|---|---|---|---|---|
0 | 0 | N/A | 0 |
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
This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.
RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our Privacy Policy.
END
UPDZZGGVVNFGMZM
(END) Dow Jones Newswires
June 08, 2021 02:00 ET (06:00 GMT)
1 Year Omega Diagnostics Chart |
1 Month Omega Diagnostics Chart |
It looks like you are not logged in. Click the button below to log in and keep track of your recent history.
Support: +44 (0) 203 8794 460 | support@advfn.com
By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions