MedMira receives CE mark for Multiplo® Complete Syphilis (TP/nTP) Antibody Test
12 Mayo 2022 - 7:40AM
Today, MedMira Inc. (MedMira) (TSXV: MIR) announces the achievement
of another milestone in its regulatory strategy by receiving the CE
mark for its Multiplo® Complete Syphilis (TP/nTP) Antibody Test
(Multiplo® TP/nTP). This approval allows the Company to further
strengthen its product offering in all markets accepting the CE
mark. By utilizing its unique RVF technology®, MedMira offers the
only commercially available combined screening and confirmation
test which takes less than 3 minutes (from sample collection to
easy-to-read results) for syphilis.
“MedMira received the CE mark in March 2022 for
its Reveal® TP (Syphilis) Antibody Test (Reveal® TP) aimed at
diagnosing potential acute syphilis infections. The product is
specifically designed for hospitals and health care providers which
have an existing screening setting such as VDRL or RPR but require
a fast confirmation test such as our Reveal® TP. MedMira’s
Multiplo® TP/nTP, on the other hand, will provide a complete system
which combines both screening and confirmation in one test. This
product is designed for clients which do not have immediate access
to VDRL or RPR such as doctor’s offices, pharmacies, and home test
users.” says Hermes Chan, CEO of MedMira. ”Our Multiplo® TP/nTP
further enhances our comprehensive product offering to our
distribution partners and clients by providing a clear answer
within minutes at the lowest possible cost. At the same time, it
increases MedMira’s brand awareness in the sexually transmitted
disease market.”
The Multiplo® TP/nTP combines the detection of
treponemal (TP) and non-treponemal (nTP) antibodies in one test.
The test targets biomarkers indicative of active as well as
previous infections, thus providing a comprehensive approach that
combines both the screening and confirmation stages employed in
testing strategies globally. Unlike traditional syphilis testing
options, our new easy-to-use, robust diagnostic solution is
MedMira’s response to the growing demand for flexible, accurate and
cost-efficient testing of syphilis. Multiplo® TP/nTP not only
identifies exposure to TP but can determine the acute infection
status through a non-treponemal screening test and a treponemal
confirmation test. This enables a complete diagnosis of syphilis on
one single device.
MedMira’s focus on syphilis is based on the
tremendous impact of this sexually transmitted disease on global
health. In 2018 alone, the European CDC reported about 34,000 new
confirmed cases of syphilis with a 70% increase in the notification
rate in 2017 compared to 2010. They also concluded that for the
first time since the early 2000s EU/EEA countries reported more
syphilis cases than HIV. Since treatments that can prevent the
progression of syphilis are available, rapid diagnosis and
treatment of infected individuals along with the rapid
identification of sexual contacts is a high priority.
Next Update
MedMira will provide a COVID-19 update
specifically for the Canada market in the coming week. Further
updates on additional CE marks and other regulatory milestone such
as the FDA will be provided within the month of May and June
2022.
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, Syphilis, Hepatitis, and SARS-CoV-2, in
just three easy steps. The Company’s tests are sold globally under
the REVEAL®, REVEALCOVID-19®, 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, product launch,
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
MedMira (TSXV:MIR)
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