MedMira Receives FDA Approval for Reveal G3 Rapid HIV Test - Fastest Rapid HIV Test in the US, Delivering Results in Less Than 3
19 Octubre 2006 - 9:23AM
PR Newswire (US)
HALIFAX, Oct. 19 /PRNewswire-FirstCall/ -- MedMira Inc.,
("MedMira") (TSX Venture: MIR, NASDAQ: MMIRF) a global market
leader in premium rapid diagnostic solutions, announced today that
it has received United States Food and Drug Administration (FDA)
approval for its Reveal(R) G3 Rapid HIV-1 Antibody Test (Reveal
G3). Reveal G3, which delivers test results in less than three
minutes, is the third generation in the Reveal line of rapid HIV
tests. Previous versions of the product were approved by the FDA in
2003 and 2004. Reveal G3 includes the addition of MedMira's
InstantGold(TM) Cap which replaces the colorimetric detection agent
used to visualize results on the test cartridge. This advancement
eliminates the need for reconstitution and refrigeration of the
colorimetric detection agent, improving the product's overall
ease-of-use. MedMira now offers Reveal G3 in a box of 30, a new
size format designed to maximize efficiency of all components
included in the test package. "We are very pleased to receive
approval on the third generation of Reveal, which brings to market
key advancements that will drive further adoption of rapid HIV
testing in point of care settings," said Hermes Chan, President
& CEO, MedMira Inc. "HIV continues to be one of the greatest
health challenges in the US and the healthcare system is taking
steps to address the control and prevention of this epidemic." On
September 21st, the US Centers for Disease Control and Prevention's
(CDC) announced new recommendations on routine HIV testing for
everyone 13 to 64 years of age. As this latest initiative takes
hold in the healthcare system, MedMira anticipates continued growth
in the rapid testing sector. The CDC estimates that there are over
250,000 HIV-positive people in the US who are unaware of their
status. The recent CDC recommendations also include enhanced
screening of pregnant women to decrease the rate of mother-to-child
transmission. Key applications for MedMira's Reveal G3 test include
Labor & Delivery, Occupational Exposures, and Emergency
Departments. MedMira's Reveal tests have ranked as a leading choice
in rapid HIV tests for US hospitals and laboratories over the past
several years. About MedMira MedMira is a leading developer and
manufacturer of flow-through rapid diagnostics. The company's tests
provide hospitals, labs, clinics and individuals around the world
with reliable, rapid diagnosis for diseases such as HIV and
hepatitis C in just three minutes. The company's tests are sold
under the Reveal(R), MiraWell(R), MiraCare(TM) and Multiplo(TM)
brands in global markets. MedMira's rapid HIV test is the only one
in the world to achieve regulatory approvals in Canada, the United
States, China and the European Union. The company's corporate
offices and manufacturing facilities are located in Halifax, Nova
Scotia, Canada with a representative office in China. For more
information visit MedMira's website at http://www.medmira.com/.
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. DATASOURCE: MEDMIRA INC. CONTACT: Dr.
James Smith, Investor Relations (902) 450-1588, ; Andrea Young,
Corporate Communications, (902) 450-1588,
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