China SFDA Approves MedMira's Whole Blood Rapid HIV Test Approval Opens Point-of-Care and Home Testing Markets in China



    HALIFAX, May 17 /PRNewswire-FirstCall/ - MedMira Inc., ("MedMira") (TSX
 Venture: MIR, NASDAQ:   MMIRF) 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.
 
 

SOURCE MedMira Inc.

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