MedMira reports additional independent performance evaluation results of REVEALCOVID-19™ Total Antibody Test
08 October 2020 - 12:28AM
Today, MedMira Inc. (MedMira) (TSXV: MIR) announces the results of
the latest independent performance evaluation results of
REVEALCOVID-19™ Total Antibody Test. The study was carried out
at a state licensed, state-of-the-art hospital in Texas (between
June and September 2020). This facility utilizes a patient-centred
model to provide 24-hour emergency care, short hospital stays, and
outpatient services. This opportunity was made possible through our
partner Webb Diagnostic Technologies.
Based on fresh blood specimens collected on
site, this study was performed to test individuals who came to the
clinic
for potential SARS-CoV-2 viral infection. A
total of 124 blood specimens were tested on site using
MedMira’s REVEALCOVID-19™ Total Antibody Test and the
results were compared to two EUA approved serological tests. One
was the Hangzhou Biotest Biotech Co., Ltd.’s COVID-19 IgG/IgM
rapid test and the other was a laboratory-based
test, Roche Elecsys’ Anti-Sars-CoV-2 Assay.
Of the 124 blood
specimens, REVEALCOVID-19™ Total Antibody Test has showed
100% agreement on 51 SARS-CoV-2 antibody positive blood specimens
as confirmed by two reference tests. 73 blood specimens were found
to be negative of SARS-CoV-2 antibody by the two reference tests.
REVEALCOVID-19™ Total Antibody Test correctly identified 71 of
the 73 negative specimens at over 97% specificity.
“STAT Specialty Hospital of Laredo were the
first Freestanding Emergency Rooms in Laredo, TX. It is a state
licensed, state-of-the art facility that utilizes a
patient-centered model to provide 24-hour emergency care, short
hospital stays and outpatient services,” said Dr. Mike Chang,
physician and managing partner, “I am pleased with the performance
of the REVEALCOVID-19™ Total Antibody Test. We found it
is simple to perform with instant results in less than 3 minutes
and excellent correlation to the two reference tests.”
“We are very pleased to announce this latest
independent performance evaluation of our test conducted by this
respected hospital where its facility is designed to uniquely
respond to the rise in consumer demand for convenience, reduced
cost, and improved access to care,” said Hermes Chan, CEO of
MedMira Inc. “It is MedMira’s commitment to develop and manufacture
near-patient tests, utilizing our patented Rapid Vertical Flow®
(RVF) technology, which provides ease of use, immediate results,
and performance to meet the end-users expectations. I would also
like to thank our trusted partner, Webb Diagnostic Technologies,
for helping to find such a reputable testing outlet and for
supporting us to conduct this study. During these difficult times,
it is a challenge to perform such studies surrounding
near-patients. We believe these results will further strengthen our
customers trust in the quality of our product”
These independent near-patient testing results obtained directly
from end-user shall further strengthen MedMira's claim towards the
respective regulators.
About MedMira
MedMira is a leading developer and manufacturer of
Rapid Vertical Flow® diagnostics. The Company’s tests provide
hospitals, labs, clinics and individuals with instant disease
diagnosis, 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-19™ Total Antibody 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 ContactMarkus MeileChief
Financial Officer, MedMira Inc.ir@medmira.com+1 902 450 1588
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