MedMira Announces Product Update
30 Dezembro 2020 - 11:00PM
Today, MedMira Inc. (MedMira) (TSXV: MIR), is pleased to announce
its validated REVEALCOVID-19
TM
PLUS Total Antibody Test for the detection of
total antibodies against both the Nucleocapsid and Spike regions of
the SARS-CoV-2. REVEALCOVID-19
TM
PLUS Total Antibody Test is an update to MedMira’s
REVEALCOVID-19
TM 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.
To ensure the EUA application for the enhanced
product, REVEALCOVID-19™ PLUS Total Antibody Test,
satisfies the EUA guidelines, MedMira is required to withdraw the
current application for the REVEALCOVID-19TM from the EUA
notification list to obtain a new EUA listing for the
REVEALCOVID-19TM PLUS Total Antibody Test. At the
same time, MedMira will submit a new interim order application to
seek Health Canada authorization of REVEALCOVID-19TM
PLUS Total Antibody Test.
“The beauty of MedMira’s RVF® Technology is the
ability to pivot toward the current needs. As the stage of the
pandemic shifts to vaccination, it is imperative that MedMira can
adjust. As a result, and in consultation with our partners, MedMira
decided to move forward with a simple solution by launching
REVEALCOVID-19TM PLUS Total
Antibody,” said Hermes Chan, CEO of MedMira Inc. “This shall enable
us to introduce the new product version and address the additional
market demands, focussing our attention on the production of 50,000
units of REVEALCOVID-19™ PLUS Total Antibody Test daily. This will
position MedMira as a major contender in the coming months, as the
vaccines are now being administered globally. The knowledge gained
during the original EUA application has been invaluable.”
About MedMira
MedMira is the developer and owner of Rapid
Vertical Flow (RVF)® Technology. The Company’s rapid test
applications built on RVF Technology 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 under the Reveal®, Multiplo® and Miriad® brands in global
markets. MedMira’s corporate offices and manufacturing facilities
are located in Halifax, Nova Scotia, Canada and the Company has a
sales and customer service office located in the United States. 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 sales of new
products, 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, the ability of
distributors and other partners to fulfil obligations and deliver
sales and other risks detailed from time to time in the company’s
annual and quarterly filings available at www.sedar.com.
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 Contacts:
Markus Meile, CFOTel: 902-450-1588Email:
ir@medmira.com
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