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.
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.