MedMira Expands its VYRA™ Product Line
Dec 22, 2021 By MarketDepth
MedMira Inc. (TSX-V: MIR) announced last night the release of its VYRA™ CoV2Flu Rapid Antigen Rapid Test.
Shares of MedMira Inc. (TSX-V: MIR) gained 13.8% during premarket hours following the announcement.
Determining Covid vs Flu
The new 3-in-1 test expands the company’s existing VYRA™ product line, and simultaneously detects the Nucleocapsid antigens of SARS-CoV-2, Influenza A and B. “We believe our VYRA™ CoV2Flu product will meet the customer needs to distinguish between COVID-19 and Influenza. With MedMira’s unique RVF® technology we are able to achieve three results with only one sample and just in less than 3 minutes,” said Hermes Chan, CEO of MedMira Inc.
Seeking FDA Approval
In addition, MedMira seeks to take advantage of the latest regulatory development surrounding the U.S. FDA De Novo/510(k) clearance, which grants numerous benefits such as “expeditious review times and a fixed classification decision lending to more certainty within the device’s regulatory lifespan.
“Furthermore, we are excited that the FDA has announced its plan to issue the final ruling of the De Novo/510(k) approval in early January 2022 to provide clarity and transparency about the FDA’s expectations and processes for De Novo classification to FDA reviewers, medical device industry, stakeholders, and the public. This will allow MedMira to have a clear path in terms of timing and product launch. While the EUA process is still an on-going and important step forward, we believe that a formal FDA approved product would be preferable by the current and future customers,”Hermes Chan, CEO of MedMira Inc.