Product and Regulatory Update on MedMira’s COVID-19 Product Family
Halifax, Nova Scotia, 03 March, 2021 – MedMira Inc. (MedMira) (TSXV: MIR) announces the expansion of its product portfolio and outlines the company’s COVID-19 market and regulatory plan.
MedMira has utilized its patented Rapid Vertical Flow® (RVF®) technology and developed the company’s first rapid antigen test,VYRA CoV-2 Antigen Test (VYRA CoV-2), designed to detect SARS-CoV-2 virus in the swab samples. VYRA CoV-2 product expands the existing COVID-19 product family and directly addresses the wishes of our customers for an equally fast, reliable, and easy-to-usetesting solution. VYRA CoV-2 saliva-based swab test is designed to be non-invasive and user-friendly, making this test more suitable for the home settings. “The successful development of this test opens up a new product line that has been a pioneering step for MedMira,” said Hermes Chan, CEO of MedMira. “With this we offer customers our COVID-19 product bundle that can accommodate various testing needs. For example, the VYRA CoV-2 can used to determine if the person is infected; REVEALCOVID-19™ PLUS [PLUS] tells if anti-SARS-CoV-2 antibodies are present; and our REVEALCOVID-19™ Nab-Y [Nab-Y] neutralizing test can potentially identify if the individual is immune to the virus.”
With the FDA’s current focus on the development of the POC and home tests, MedMira received the pre- EUA submission number for its PLUS product to also include the POC claim. Once authorized by the FDA for distribution in the US, MedMira expects to maximizethe sale potential in the current market environment. In preparation for the home test application, MedMira is now working on collecting additional performance data required by the Agency.
MedMira will send the pre-EUA requests to seek the FDA authorization for REVEALCOVID-19™ Nab-Y and VYRA CoV-2 products, including the information required to support the POC claim. MedMira is working on the collaboration with the National Microbiology Lab to fulfill the additional requirements of the second Interim Order. In the meantime, MedMira’s REVEALCOVID-19™ Total AntibodyTest is sold in the European Union and is highly valued by our European customers.