Omega Diagnostics Group PLC CE-Mark for VISITECT® CD4 Advanced Disease test (0861T)
18 March 2019 - 6:00PM
UK Regulatory
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.
END
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