extremely easy not to believe in Medmira Halifax, Nova Scotia, 30 December, 2020 – Today, MedMira Inc. (MedMira) (TSXV: MIR), is pleased to announce its validated REVEALCOVID-19TM PLUS Total Antibody Test for the detection of total antibodies against both the Nucleocapsid and Spike regions of the SARS-CoV-2. REVEALCOVID-19TM PLUS Total Antibody Test is an update to MedMira’s REVEALCOVID-19TM Total Antibody Test that addresses the total antibody testing demands arising from recent developments in COVID-19 vaccines across global markets.
To ensure the EUA application for the enhanced product, REVEALCOVID-19™ PLUS Total Antibody Test, satisfies the EUA guidelines, MedMira is required to withdraw the current application for the REVEALCOVID-19TM from the EUA notification list to obtain a new EUA listing for the REVEALCOVID-19TM PLUS Total Antibody Test. At the same time, MedMira will submit a new interim order application to seek Health Canada authorization of REVEALCOVID-19TM PLUS Total Antibody Test. “
“The beauty of MedMira’s RVF® Technology is the ability to pivot toward the current needs. As the stage of the pandemic shifts to vaccination, it is imperative that MedMira can adjust. As a result, and in consultation with our partners, MedMira decided to move forward with a simple solution by launching REVEALCOVID-19TM PLUS Total Antibody,” said Hermes Chan, CEO of MedMira Inc. “This shall enable us to introduce the new product version and address the additional market demands, focussing our attention on the production of 50,000 units of REVEALCOVID19™ PLUS Total Antibody Test daily. This will position MedMira as a major contender in the coming months, as the vaccines are now being administered globally. The knowledge gained during the original EUA application has been invaluable”.
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Furthermore, the Company has made further progress on its regulatory work in United States. While the EUA process is on-going, the Company has prepared the necessary De Novo 510(k) pre-submissions for its REVEALCOVID-19® and VYRATM product lines. At this stage the regulators are yet to release the final requirements for the acceptance. The Company is confident to fulfill these requirements for all its products and has completed all the necessary preparations to immediately commence.