Halifax, Nova Scotia, 21 December, 2021 – Today, MedMira Inc. (MedMira) (TSXV: MIR) announces the expansion of its VYRATMproduct line by launching its VYRA™ CoV2Flu Rapid Antigen Rapid Test (VYRA™ CoV2Flu). Based on MedMira’s proprietary technology, this 3-in-1 test is developed to distinguish between SARS-CoV-2 and Influenza A or B infections. Furthermore, the Company takes advantage of the latest regulatory development surrounding the US FDA De Novo/510(k) clearance processes by applying for its COVID-19 products.
The VYRA™ CoV2Flu Test simultaneously detects the Nucleocapsid antigens of SARS-CoV-2, Influenza A and B. Three distinguish results can be obtained in a matter of a few minutes. The test has demonstrated the ability to detect the Influenza A and B viruses from a testing panel including the Influenza A (Brisbane/59/07, Brisbane/10/07, Perth/16/2009, Solomon Islands/03/2006, New Caledonia/20/99, Swine NY/01/2009 and Swine Canada/6294/09) and the Influenza B (Lee/40, Florida/02/2006, Brisbane/33/2008, Panama/45/90). These positive specimens are all confirmed by FDA cleared Influenza rapid tests.
“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 minutes. MedMira is seeking CE Marking for VYRA™ CoV2Flu concurrently to our EUA and De Novo/510(k) route in the United States. We anticipate the product launch first in Europe in early 2022, together with our REVEALCOVID-19® product line, and subsequently in the USA.” said Hermes Chan, CEO of MedMira Inc. “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.”
The FDA issued a Final Rule regarding the De Novo/510(k) Classification Request process, a fast and efficient pathway for manufacturers of novel medical devices seeking marketing authorization as a Class I or Class II device. The advantages of the De Novo Classification Request for new devices include expeditious review times and a fixed classification decision lending to more certainty within the device’s regulatory lifespan. These advantages align with MedMira’s long-term vision for its upcoming SARS-CoV-2 diagnostic devices, and the Company is prepared to submit a De Novo Classification Request for our REVEALCOVID-19® and VYRA™ products when the rule becomes effective in January 2022. MedMira’s most recent certification for Medical Device Single Audit Program (MDSAP), completion of the FDA routine inspection and detailed preparation will contribute to a straightforward review by the FDA. The De Novo/510(k) applications will be in parallel to the EUA applications.