China SFDA Approves MedMira's Whole Blood Rapid HIV Test
17 Mayo 2006 - 10:38AM
PR Newswire (US)
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
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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