MedMira Completes CE Mark Facilities Inspection
December 08 2005 - 9:49AM
PR Newswire (US)
MiraCare Rapid HIV Antibody Test Poised for Sales in European
Market HALIFAX, Dec. 8 /PRNewswire-FirstCall/ -- MedMira Inc.,
("MedMira") (TSX Venture: MIR, NASDAQ: MMIRF) the global market
leader in flow-through rapid diagnostic technology, announced today
that it has successfully completed its quality systems assessment
inspection, the final stage of the approval process. The final CE
approval is expected shortly which will allow MedMira's MiraCare
Rapid HIV Antibody Test ("MiraCare HIV") to be sold in the European
Union ("EU"). The EU represents 25 member countries and a total
population of 440 million, nearly a hundred million more than the
United States. According to UNAIDS, HIV infections have increased
in the EU by over 100,000 new cases in 2004. MiraCare HIV is
MedMira's newest generation product, and is currently sold
over-the-counter in Hong Kong and Macao, China. In Europe, the
MiraCare HIV test will be approved for use with whole blood, as
well as serum and plasma - a truly complete rapid HIV test suitable
for all settings, from near- patient use in pharmacies to hospitals
and clinical laboratories. MiraCare HIV is sold as a complete
package with all components required for an individual to conduct
the test quickly, taking only three minutes from the start of the
test procedure to receipt of the test result. "We are very pleased
to reach this major milestone in our strategic market expansion in
Europe," said Stephen Sham, Chairman and CEO of MedMira. "Our
MiraCare HIV test is poised to enter one of the most lucrative
global diagnostic markets where rapid testing for HIV is just
starting to take off and ours will be the fastest test in the
market. Through entering the EU, we will continue to see our
success expanding from one end of the world to the other." 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. Health Canada, the United
States FDA and the SFDA in the People's Republic of China have
approved MedMira's rapid HIV tests. MedMira's 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,
MedMira's over-the-counter (OTC) product, is available in
pharmacies throughout Hong Kong and Macao Special Administrative
Regions, in the People's Republic of China. 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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