HALIFAX, Jan. 17 /PRNewswire-FirstCall/ - MedMira Inc., (“MedMira”) 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 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
