MedMira Receives FDA Approval for Enhancements to Rapid HIV Test
10 Maio 2005 - 10:29AM
PR Newswire (US)
MedMira Receives FDA Approval for Enhancements to Rapid HIV Test
New Features Improve Cost Effectiveness and Provide More
Flexibility HALIFAX, May 10 /PRNewswire-FirstCall/ -- MedMira Inc.,
("MedMira") (TSX Venture: MIR, NASDAQ: MMIRF) the global market
leader in rapid flow-through diagnostic technology, announced today
that it has received approval from the United States Food and Drug
Administration (FDA) to provide new features in its Reveal(TM) G2
Rapid HIV-1 Antibody Test. These enhancements will continue to
heighten the competitiveness of Reveal(TM) G2 in the marketplace
and further increase customer satisfaction. This latest FDA
approval enables MedMira to provide external control material with
an extended shelf-life and additional flexibility, answering the
emerging challenges and needs of the market. US laboratory
professionals are subject to strict quality control requirements,
and MedMira's enhancement to the external controls will improve
cost-effectiveness and versatility for the customer. Reveal(TM) G2
is currently the fastest rapid HIV test, at only 3-minutes,
available in the United States and according to an independent
study by the US Centers for Disease Control and Prevention (CDC),
is the number one rapid HIV test used in US hospitals. "MedMira's
compliance and technology team has, again, successfully navigated
the complex US regulatory process. Our increasing experience in
meeting the FDA's requirements will facilitate future expansion of
our product line in the United States," said Hermes Chan, president
and COO of MedMira. Over 180,000 HIV testing locations, including
laboratories and hospitals, conduct an estimated 28 million HIV
tests each year in the United States. MedMira anticipates continued
sales growth and expansion of its rapid flow- through testing
platform in the United States. About MedMira MedMira is the leading
global manufacturer and marketer of in vitro flow- through rapid
diagnostic tests for the clinical laboratory market. 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. The United States FDA and the SFDA in the
People's Republic of China have approved MedMira's Reveal(TM) G2
and MiraWell(TM) Rapid HIV Tests, respectively. MedMira's
Reveal(TM) G2 and MiraWell(TM) rapid HIV tests are currently used
in clinical laboratories and hospitals 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 the Hong Kong and Macao Special
Administrative Regions, in the People's Republic of China. MedMira
markets its rapid tests worldwide in such countries as the United
States, Canada, South Africa and China. Its corporate offices and
manufacturing facilities are located in Halifax, Nova Scotia,
Canada with a representative office in Beijing, 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: Contact:
Dr. James Smith, Investor Relations, Tel: (902) 450-1588, E-mail:
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