HALIFAX, May 17 /PRNewswire-FirstCall/ - MedMira Inc., (“MedMira”) the global market leader in premium rapid diagnostic solutions, announced today that it has received approval from the State Food and Drug Administration (SFDA) of the People’s Republic of China for its MiraWell(R) Rapid HIV Test (MiraWell HIV) for use with whole blood specimens. MedMira’s test is the first and only whole blood rapid HIV test to fulfill the rigorous clinical requirements of the Chinese regulatory body. The MiraWell HIV test offers users instant results and has a shelf life of two years at room temperature storage.
“We are very pleased to receive fast tracked approval of our whole blood rapid HIV test and view this as another major step taken by the government to stop the wide spread of HIV infection in China,” said Stephen Sham, Chairman and CEO of MedMira. “As the first and only instant rapid HIV test approved in China for all types of blood specimens including; finger-stick whole blood, venous whole blood, serum, and plasma, we have generated a significant and unique competitive advantage in a crowded marketplace. We will continue to pursue new opportunities, including the home testing market, in this critical global market.”
The MiraWell HIV test for use with serum/plasma was initially approved by the SFDA in 2003 and since that time faced many domestic competitors in the China market. MedMira pursued whole blood approval to differentiate itself in this marketplace and meet the growing demand for rapid point-of-care testing. With whole blood approval now in place MedMira will develop market opportunities in the over-the-counter sector, for further penetration into China.
Sham continued, “Our goal is to bring easy-to-use, quality rapid diagnostics closer to the patient. With whole blood approval in China we can now offer a lab-focused product as well as point-of-care tests. Soon, we will pursue the over-the-counter market, building on our experience gained in Hong Kong and Macao, where we have sold rapid HIV tests in pharmacies since early 2005.”
The MiraWell HIV test for use with whole blood will be offered in single, all-in-one test kit packs and a package containing 30 tests, and features a shelf-life of two years at room temperature. Both of these features are critical to the point-of-care and over-the-counter markets. Choice in test kit formats and a longer shelf-life at room temperature enable small and large organizations, and individuals to purchase according to their needs and conduct HIV testing in a broad range of environments, including mobile clinics, physician’s offices, and at home.
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, the SFDA in the People’s Republic of China and European Union have approved MedMira’s Reveal(R) G2, MiraWell(R) and MiraCare(TM) 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.
MiraCare(TM) is sold through MedMira’s distributor network to pharmacies, hospitals and laboratories in the European Union. It is also available over- the-counter (OTC) 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 and joint venture manufacturing facility 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
