MedMira Inc., announced that it had submitted the notification for the Emergency Use Authorization application offered by the U.S. Food and Drug Administration for its newest member of its Reveal line of products for antibody testing.
HALIFAX, Nova Scotia, April 23, 2020 (GLOBE NEWSWIRE) -- MedMira Inc. (MedMira) (TSXV: MIR), announced today that it had submitted the notification for the Emergency Use Authorization application offered by the U.S. Food and Drug Administration (FDA) for its newest member of its Reveal line of products for antibody testing. The FDA policy announced on March 16, 2020 permits MedMira to begin U.S. sales of REVEALCOVID-19TM total antibody test immediately while it awaits FDA clearance under Emergency Use Authorization (EUA).
“Completion of the validation, and the notification to the FDA is a key step in our efforts to bring our newest test to market in an attempt to help the COVID-19 pandemic situations. The Company’s full submission for EUA is currently in preparation.” said Hermes Chan, CEO, “Our Rapid Vertical Flow® technology, with no timer or reader requirement, allows all our rapid tests to be used in various settings and provides an immediate clearly visible result.”
MedMira, with its over 20 years of experience, has a proven track record to provide high quality, simple and rapid tests for a number of diseases. REVEALCOVID-19TM total antibody test 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. This versatility and speed will enable fast and reliable results for detection of any antibodies such as IgM, IgG and IgA from the SARS-COV-2 virus.
About MedMira
MedMira is a leading developer and manufacturer of vertical flow rapid diagnostics. The Company’s tests provide hospitals, labs, clinics and individuals with instant diagnosis for diseases such as HIV and Hepatitis C in just three easy steps. The Company’s tests are sold globally under the Reveal®, Multiplo® and Miriad® brands. Based on its patented Rapid Vertical Flow Technology®, MedMira’s rapid HIV test is the only one in the world to achieve regulatory approvals in Canada, the United States, China and the European Union. MedMira’s corporate offices and manufacturing facilities are located in Halifax, Nova Scotia, Canada. For more information visit medmira.com. Follow us on Twitter and LinkedIn.
This news release contains forward‐looking statements, which involve risk and uncertainties and reflect the Company’s current expectation regarding future events, including statements regarding possible regulatory approval and launch of the REVEALCOVID-19TM test, future growth, and new business opportunities. Actual events could materially differ from those projected herein and depend on a number of factors including, but not limited to, changing market conditions, successful and timely completion of clinical studies, uncertainties related to the regulatory approval process, establishment of corporate alliances and other risks detailed from time to time in the company quarterly filings.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
MedMira Contact:
Markus Meile
Chief Financial Officer, MedMira Inc.
ir@medmira.com
