Omega Diagnostics Group PLC VISITECT® CD4 update (9417R)
March 06 2019 - 2:00AM
UK Regulatory
TIDMODX
RNS Number : 9417R
Omega Diagnostics Group PLC
06 March 2019
OMEGA DIAGNOSTICS GROUP PLC
("Omega" or the "Company" or the "Group")
VISITECT(R) CD4 update
Omega (AIM: ODX), the medical diagnostics company focused on
allergy, food intolerance and infectious disease, announces that it
has received its first purchase orders for its VISITECT(R) CD4 350
cut-off test and continues to make progress with its VISITECT(R)
CD4 Advanced Disease test.
VISITECT(R) CD4 350 cut-off test
The Company is pleased to report that it has received its first
purchase orders for its CE-Marked VISITECT(R) CD4 350 cut-off test
from distributors supplying into Indonesia, Moldova and Papua New
Guinea. As expected by the Company, the order quantities are low at
this stage and reflect distributors' intentions to seed their
private business-to-business market channels in the initial stages.
Nevertheless, this is an endorsement of the Company's ability to
develop and then commercialise this product through the regulatory
processes in international markets. We expect to supply customers
before the end of the current financial year.
As previously indicated, we see Nigeria as being the single
largest market for this version of the test and, whilst we are
still awaiting our first order from Nigeria pending a performance
evaluation, we remain confident of the potential to deliver
shareholder value from this opportunity. We have received ethics
approval from the National Health Research Ethics Committee of
Nigeria and will provide a further update on progress of the
evaluation in due course.
VISITECT(R) CD4 Advanced Disease test
Our VISITECT(R) CD4 Advanced Disease test utilises a lower
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.
We have now achieved two further key milestones for this
project:
-- The successful completion of all internal verification studies by our development team.
-- The successful completion of an external performance
evaluation of venous whole blood samples.
These studies have completed in line with management's expected
timelines and, to CE-Mark our Advanced Disease test, we are now
only required to complete an external performance evaluation of
finger prick blood samples. Progress with these evaluations is
currently tracking to plan with a significant number of samples
completed in Zimbabwe and India. Results to date from both sites
demonstrate that the test is performing in line with design goals
and we are therefore confident that we will CE-Mark this product by
the end of March 2019. Achieving this critical milestone is a
further step towards completing the additional regulatory processes
needed to supply this product into the NGO community.
Colin King, Chief Executive of the Group, commented: "We are
pleased to have commercialised our VISITECT(R) CD4 350 cut-off test
in the current financial year and I remain confident with both the
near term opportunity in Nigeria and the fact that our team has
shown that they can take a developed product through complex
registration processes to commercialisation. In addition, the
Advanced test continues to track against our timeline, which
further demonstrates the significant improvements in our ability to
deliver against our promises. This all bodes well for delivering
meaningful revenues for CD4 in the next financial year."
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
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END
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