Halifax, Nova Scotia, 15th of April, 2020 – MedMira Inc. (MedMira) (TSXV: MIR), announced today that it has completed the development of the serological Point-of-Care (POC) testing solution with immediate result. Based on MedMira’s unique and patented Rapid Vertical Flow® (RVF) technology, the newly developed REVEALCOVID-19™ delivers immediate results without the need for any additional equipment such as a reader or a timer. The product is subject to obtaining regulatory approvals to sell in the selected markets. MedMira’s aim is to provide a reliable screening tool to relieve overburdened healthcare providers allowing for faster turn-around times with a rapid and reliable testing solution.
Based on it’s proven and highly flexible RVF technology, MedMira’s in-house R&D team has developed and validated its REVEALCOVID-19™, a serological total antibody test. The product is ready to submit to the relevant regulators such as FDA through its Notification/Emergency Use Authorization process as announced on March 16, 2020 by FDA. This test has been listed on the COVID-19 Diagnostic Device Applications by Health Canada.
The test can be completed under 3 minutes (from the blood drawn until the testing is completed) and provides an instant result. It can be used with whole blood, serum or plasma and is also ideal for batch testing in laboratory settings, meeting the needs of all possible users across a broad range of testing environments.
Total Antibody Positive Result shown above Total Antibody Negative Result shown above
The REVEALCOVID-19™ is designed to detect all antibodies found in individuals who have been exposed to SARS-CoV-2 virus, the virus that causes COVID-19 disease. The test in combination with molecular diagnostic testing will aid health care professionals to make the most accurate assessment of the status of patients. Rapid diagnostic tools such as MedMira’s test are urgently needed to assess and help to control the spread of the pandemic. This in-house developed test has been validated by MedMira’s scientific research team with over 20 years experience in In Vitro diagnostics using blood specimens obtained from RT-PCR confirmed patients.
“MedMira’s patented technology has been proven to provide the fastest and highest-quality testing solutions for HIV, Syphilis, Hepatitis B and C and has obtained regulatory approvals for selected products in many parts of the world. The latest member of our REVEAL family, REVEALCOVID-19™, is expected to bring the much needed protection to both healthcare providers and their patients,” said Hermes Chan, CEO of MedMira Inc. “This provides a vital, realistic, timely and effective testing solution that showcases the capability of our RVF technology. It is paramount to identify those who are infected with, or who have been exposed to the virus and also to monitor those who are at high risk. Our existing business is the development and sales of antibody tests for HIV and Hepatitis, and we have internal lab and manufacturing facilities that are FDA certified and staffs who have been engaged in similar R&D for over 20 years.”
MedMira’s CSO has approved the scientific disclosure contained in the press release.