MedMira Announces Product Update
HALIFAX, Nova Scotia, Dec. 30, 2020 (GLOBE NEWSWIRE) -- 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.
The two vaccines from Pfizer and Moderna, which were recently authorized for use in the United States and Canada, generate neutralizing antibodies against the Spike protein of the SARS-CoV-2 virus in order to provide the necessary protection of vaccinated individuals. The discovery of at least two new mutations of the SARS-CoV-2 Spike protein leads to a more urgent need to enhance the antibody test with the capability to detect the antibodies against those specific regions. REVEALCOVID-19TM PLUS Total Antibody Test is designed to add the ability to detect antibodies to Spike to the current detection capability of MedMira’s previous REVEALCOVID-19 Total Antibody Test (i.e. SARS-CoV-2 Nucleocapsid protein). MedMira sees significant value in launching the enhanced REVEALCOVID-19TM PLUS Total Antibody Test for the simultaneous detection of antibodies to both Nucleocapsid and Spike proteins. This new advancement shares the same easy-to-use features with the previous product version, while adding a modified Spike antigen to address the growing total antibody testing need for both pre- and post-vaccination. This new advancement shares the same easy-to-use features as the previous version, while adding a modified Spike antigen within the detection formulation.
MedMira has completed the validation studies of REVEALCOVID-19 PLUS Total Antibody Test using the required number of positive and negative blood specimens, demonstrating that the test performance meets the regulatory requirements, as per the latest United States Food and Drug Administration (the “U.S. FDA”) Emergency Use Authorization (“EUA”) template. The test has also been subjected to the cross-reactivity study using 50 HIV positive specimens and found the specificity is 100%. A new EUA application will be submitted to the U.S. FDA within 10 business days.
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