MedMira Receives CE Mark for MiraCare Rapid HIV Test
17 Janeiro 2006 - 1:42PM
PR Newswire (US)
Europeans Now Have Access to First Instant Rapid HIV Test HALIFAX,
Jan. 17 /PRNewswire-FirstCall/ -- MedMira Inc., ("MedMira") (TSX
Venture: MIR, NASDAQ: MMIRF) the global market leader in premium
rapid diagnostic solutions, announced today that its MiraCare(TM)
Rapid HIV Antibody Test (MiraCare(TM)) has received CE Mark and is
now approved for sale throughout the European Union (EU). This
regulatory milestone clears the way for MedMira to market and sell
MiraCare(TM) in the 25 EU member countries, a market which, up
until now, had limited choice in quality rapid HIV tests. MedMira's
rapid HIV test platform stands alone as the only test to receive
regulatory approvals in four top tier international forums; Canada,
the United States, China and the European Union. This is a clear
indication of its highest standard in quality and performance. "We
are very pleased to receive the CE Mark, the final step in the pre-
market process. MedMira is now fully enabled to move forward with
fulfillment of our first order for 400,000 MiraCare(TM) tests
destined for Spain and capitalize on further sales opportunities in
other regions of the EU," said Stephen Sham, chairman and CEO of
MedMira. "Once again, we have proven our abilities to navigate
regulatory processes globally, and this milestone is further
testament to the high quality and accuracy of our rapid tests."
Sham continued, "Obtaining the CE Mark for MiraCare(TM) lays a
solid foundation for EU regulatory approval of MedMira's entire
suite of rapid diagnostics, including our combination HIV/Hepatitis
C rapid test." MiraCare(TM) is the first and only rapid HIV test
developed and manufactured in North America to obtain CE Mark.
Approved for use with whole blood, as well as serum and plasma
specimens, MiraCare(TM) is a truly versatile rapid HIV test for
near-patient settings such as pharmacies and hospitals, as well as
laboratories, in Europe. It is sold as a complete test kit with all
components required to perform the test and provides patient test
results instantly. Placement of CE Mark on a product indicates that
it is in compliance with the rigorous quality, design and
performance standards dictated by the EU directives, which are
required for all medical devices sold in Europe. MiraCare(TM)
achieved CE Mark after comprehensive review of its product design
dossier, clinical trial data, and successful completion of a
facilities inspection. About MedMira MedMira is the leading global
manufacturer and marketer of in vitro flow- through rapid
diagnostic tests. MedMira's tests provide reliable, rapid diagnosis
in just 3 minutes for the detection of human antibodies in human
serum, plasma or whole blood for diseases such as HIV and hepatitis
C. The United States FDA and the SFDA in the People's Republic of
China have approved MedMira's Reveal(R) G2 and MiraWell(R) rapid
HIV tests, respectively. MedMira's Reveal(R) G2 and MiraWell(R)
rapid HIV tests are currently used in clinical laboratories,
hospitals, and clinics where professional counselling and patient
treatment are immediately available. The MiraCare(TM) Rapid HIV
Antibody Test is available over-the-counter (OTC) in pharmacies
throughout Hong Kong and Macao Special Administrative Regions, in
the People's Republic of China. MiraCare(TM) is sold through
MedMira's distributor network to pharmacies, hospitals and
laboratories in the European Union. MedMira delivers rapid
diagnostic solutions to healthcare communities around the globe.
Its corporate offices and manufacturing facilities are located in
Halifax, Nova Scotia, Canada with a representative office in
Guilin, China. This news release contains forward-looking
statements, which involve risk and uncertainties and reflect the
company's current expectation regarding future events. 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. The
TSX Venture Exchange has not reviewed and does not accept
responsibility for the adequacy or accuracy of this statement. For
more information visit MedMira's website at
http://www.medmira.com/. DATASOURCE: MedMira Inc. CONTACT: Dr.
James Smith, Investor Relations, Tel: (902) 450-1588, E-mail: ;
Andrea Young, Corporate Communications, Tel. (902) 450-1588, Email:
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