Omega Diagnostics Group PLC CE-Mark for self-test for VISITECT(R) COVID-19 test (5386A)
03 Febrero 2022 - 12:59AM
UK Regulatory
TIDMODX
RNS Number : 5386A
Omega Diagnostics Group PLC
03 February 2022
OMEGA DIAGNOSTICS GROUP PLC
("Omega" or the "Company" or the "Group")
CE-Mark for self-test for VISITECT(R) COVID-19 antigen test
Omega (AIM: ODX), the specialist medical diagnostics company
focused on industry-leading Global Health (CD4 and COVID-19) and
Health and Nutrition products announces that it has successfully CE
marked its VISITECT(R) COVID-19 antigen test for self-test use.
The test will provide consumers with an accurate rapid test for
the detection of the nucleoprotein of the SARS-CoV-2 virus in nasal
swabs only. The VISITECT(R) COVID-19 antigen test has excellent
performance characteristics following independent multi-centre
validations, with sensitivity of 93.2% based on 103 samples with
cycle threshold (Ct) values <25, and 97.8% specificity, based on
230 RT-qPCR negative samples.
The Company remains in discussions with commercial partners
about how best to service the European market and other territories
that recognise the CE mark. Omega's commercial offering will be via
B2B partners and distributors, and not through a direct-to-consumer
strategy.
The CE Mark certificate is conditional upon the submission of
additional data and follow-up reports by 31 March 2022 and Omega is
working closely with its external study centres to ensure this
deadline is met.
Omega remain in the review process under CTDA regulations, which
were introduced on 1 November 2021. Further field study data has
been recently requested. Omega is seeking this information from
external parties but this may not be available prior to the current
extended deadline for submission of 10 February 2022.
Jag Grewal, CEO of Omega, commented: "We are delighted to have
reached this milestone, achieving CE Mark for our VISITECT(R)
COVID-19 antigen test for the home-use market. It is frustrating
that our test is still awaiting approval under CTDA regulations for
sale of the professional-use test in the UK. We will now look to
begin the process of filing for approval to sell our home-use
product in the UK. In the meantime, we look forward to working with
prospective partners to determine the best route to market."
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 www.omegadiagnostics.com
Jag Grewal, Chief Executive Officer via Walbrook PR
Chris Lea, Chief Financial Officer
finnCap Ltd Tel: 020 7220 0500
Geoff Nash / Edward Whiley (Corporate
Finance)
Alice Lane / Charlotte Sutcliffe (ECM)
Walbrook PR Limited Tel: 020 7933 8780 or omega@walbrookpr.com
Paul McManus / Lianne Applegarth Mob: 07980 541 893 / 07584 391
303
Sam Allen Mob: 07502 558 258
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.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
MSCEADAAEASAEAA
(END) Dow Jones Newswires
February 03, 2022 01:59 ET (06:59 GMT)
Omega Diagnostics (LSE:ODX)
Gráfica de Acción Histórica
De Feb 2024 a Mar 2024
Omega Diagnostics (LSE:ODX)
Gráfica de Acción Histórica
De Mar 2023 a Mar 2024