Omega Diagnostics Group PLC VISITECT® CD4 CE-Mark (7714X)
29 November 2017 - 6:00PM
UK Regulatory
TIDMODX
RNS Number : 7714X
Omega Diagnostics Group PLC
29 November 2017
Omega Diagnostics Group PLC
("Omega" or the "Company")
VISITECT(R) CD4 CE-Mark
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 test for helping to manage people
living with HIV, following successful performance evaluations in
India and the UK.
The successful completion of the CE-Mark process means these
tests, which indicate whether a person's CD4 count is higher or
lower than 350 cells/mm(3), are available for general sale through
business to business channels in countries not requiring individual
product registration. The technical file forms the basis of the
additional regulatory approval the Company will seek through the
World Health Organisation Prequalification programme which assesses
in vitro diagnostics tests for priority diseases and their
suitability for use in resource-limited settings. A successful
completion of this process will enable Omega to become eligible for
public sector procurement. The Company anticipates that this
process is likely to be completed during the second half of the
next financial year.
In addition, the Company is looking to expand its VISITECT(R)
product portfolio and is working on an additional version of the
VISITECT(R) CD4 test which utilises a 200 cells/ mm(3) cut-off.
Recent global health guidelines confirm an opportunity also exists
for a test that can indicate advanced HIV disease (a CD4 cell count
which is lower than 200 cells/mm(3)) and the Company is working to
ensure it has a product portfolio encompassing both existing and
new opportunities.
Andrew Shepherd, Chief Executive Officer of Omega, commented:
"We are pleased to have achieved this major milestone and whilst
the early opportunities are likely to lead to modest sales during
the next twelve months, we anticipate generating significant demand
once we have completed all the regulatory hurdles. We look forward
to providing the global health community with unique point-of-care
tests which address a significant unmet need."
Contacts:
Omega Diagnostics Group Tel: 01259 763 030
PLC
Andrew Shepherd, Chief www.omegadiagnostics.com
Executive
Kieron Harbinson, Group
Finance Director
Jag Grewal, Group Sales
and Marketing Director
finnCap Ltd Tel: 020 7220 0500
Geoff Nash/James Thompson
(Corporate Finance)
Mia Gardner (Corporate
Broking)
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 company news service from the London Stock Exchange
END
RESUWVNRBUAAUAA
(END) Dow Jones Newswires
November 29, 2017 02:00 ET (07:00 GMT)
Omega Diagnostics (LSE:ODX)
Historical Stock Chart
From Apr 2024 to May 2024
Omega Diagnostics (LSE:ODX)
Historical Stock Chart
From May 2023 to May 2024