HALIFAX, Dec. 8 /PRNewswire-FirstCall/ - MedMira Inc., (“MedMira”) 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 www.medmira.com.
MedMira Inc.
CONTACT: Dr. James Smith, Investor Relations, Tel: (902) 450-1588, E-mail:ir@medmira.com; Andrea Young, Corporate Communications, Tel. (902)450-1588, Email: ayoung@medmira.com
