Omega Diagnostics Group PLC Update on validation under CTDA legislation (4089E)
11 Marzo 2022 - 1:00AM
UK Regulatory
TIDMODX
RNS Number : 4089E
Omega Diagnostics Group PLC
11 March 2022
The information contained within this announcement is deemed by
the Company to constitute inside information as stipulated under
the Market Abuse Regulation (EU) No. 596/2014. Upon the publication
of this announcement via the Regulatory Information Service, this
inside information is now considered to be in the public
domain.
OMEGA DIAGNOSTICS GROUP PLC
("Omega" or the "Company" or the "Group")
Update on validation under CTDA legislation
Omega (AIM: ODX), the specialist medical diagnostics company
focused on industry-leading Health & Nutrition and Global
Health (CD4 and COVID-19) products, has been informed by the UK
Health Security Agency that the application for approval of the
professional-use VISITECT(R) COVID-19 Antigen test under the
Medical Devices (Coronavirus Test Device Approvals) (Amendment)
Regulations 2021 ("CTDA") has been unsuccessful, and accordingly
the product will not be available for sale in the general UK
market.
Some supporting data provided by third-party development
partners and submitted for the Desktop Review used comparator
RT-qPCR (Quantitative reverse transcription PCR) results from
studies conducted in late 2020 and early 2021 and pre-date the CTDA
regulations. Certain of these comparator tests were not CE-marked
and/or did not meet the sensitivity/specificity requirements
subsequently specified in the CTDA regulations. These results
therefore had to be excluded from the review and, as a consequence,
there are now insufficient test results to meet the CTDA
requirements. Currently, with insufficient demand for the
professional-use test, the Company does not plan to commission
further studies at this time.
The Directors believe that the self-test market is much more
relevant in terms of opportunity and Omega continues to work
closely with its external study centres to ensure the 31 March 2022
deadline is met for the submission of the outstanding self-test CE
Mark data.
Jag Grewal, CEO of Omega, commented: "Whilst this is clearly
disappointing, our plans do not include any contribution from
COVID-19 antigen tests, as we focus the business on driving growth
in our Health & Nutrition division."
Contacts:
Omega Diagnostics Group PLC www.omegadx.com
Jag Grewal, Chief Executive Officer via Walbrook PR
Chris Lea, Chief Financial Officer
finnCap Ltd Tel: 020 7220 0500
Geoff Nash/Edward Whiley/George Dollemore (Corporate
Finance)
Alice Lane/ Charlotte Sutcliffe
(ECM)
Walbrook PR Limited Tel: 020 7933 8780 or omega@walbrookpr.com
Paul McManus Mob: 07980 541 893
Lianne Applegarth Mob: 07584 391 303
Sam Allen Mob: 07502 558 258
About Omega Diagnostics Group PLC
Omega manufactures and distributes high quality in-vitro
diagnostic products for use in hospitals, clinics, laboratories and
healthcare practitioners in over 75 countries and specialise in the
areas of health and nutrition and global health.
www.omegadx.com
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END
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