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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 : 0861T
Omega Diagnostics Group PLC
18 March 2019
OMEGA DIAGNOSTICS GROUP PLC
("Omega" or the "Company" or the "Group")
CE-Mark for VISITECT(R) CD4 Advanced Disease test
Omega (AIM: ODX), the medical diagnostics company focused on allergy, food intolerance and infectious disease, announces that it has CE-Marked its VISITECT(R) CD4 Advanced Disease test for monitoring people living with HIV.
The VISITECT(R) CD4 Advanced Disease test utilises a cut-off of 200 CD4 cells/mm(3) of blood, a level at which patients' immune systems are so weakened by HIV that they are at risk of infection by other life-threatening diseases.
The technical file supporting the CE-Mark will form the basis of the additional regulatory approvals that the Company will seek through the UNITAID-funded Expert Review Panel for Diagnostics ("ERPD"), hosted by the Global Fund to Fight AIDS, Tuberculosis and Malaria. The ERPD outcome is a time-limited, risk-based recommendation on eligibility for procurement whilst the Company undergoes the World Health Organisation Prequalification programme. This programme aims to ensure that clinical diagnostics, medicines and vaccines meet global standards of quality, safety and efficacy, in order to optimise the use of health resources and improve health outcomes.
Colin King, Chief Executive of the Group, commented: "We are pleased to have reached the milestone of attaining the CE-Mark for our VISITECT(R) CD4 Advanced Disease test within the timeframe we previously set out. Together with our currently commercialized VISITECT(R) CD4 350 test, we intend to provide easy to use, clinically relevant CD4 testing to less advantaged communities around the world. We look forward to working with the Global Health community to bring this unique test to the market to make a positive impact on the lives of many people living with HIV."
The information communicated in this announcement is inside information for the purposes of Article 7 of EU Regulation 596/2014.
Contacts:
Omega Diagnostics Group PLC Tel: 01259 763 030 Bill Rhodes, Interim Non-Executive www.omegadiagnostics.com Chairman Colin King, Chief Executive Kieron Harbinson, Group Finance Director finnCap Ltd Tel: 020 7220 0500 Geoff Nash/James Thompson (Corporate Finance) Camille Gochez (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.
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March 18, 2019 03:00 ET (07:00 GMT)
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