Update on validation under CTDA legislation
11 March 2022
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® 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.”
|Omega Diagnostics Group PLC||www.omegadx.com|
|Jag Grewal Chief Executive Officer||via Walbrook PR|
|Chris Lea, Chief Financial Officer|
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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