MedMira Announces Notification Submission to US FDA Emergency Use Authorization
23 April 2020 - 9:00PM
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-19
TM 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 MeileChief Financial Officer,
MedMira Inc.ir@medmira.com
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