Health Canada Approves New MedMira Rapid HIV Test
October 21 2004 - 4:20PM
PR Newswire (US)
Health Canada Approves New MedMira Rapid HIV Test Achieves Second
North American Regulatory Success HALIFAX, Oct. 21
/PRNewswire-FirstCall/ -- MedMira Inc. ("MedMira") (TSX Venture:
MIR, NASDAQ:MMIRF) the global market leader in flow-through
diagnostics for infectious diseases, announced today that it has
received approval from Health Canada to market and sell its
enhanced MedMira(TM) Rapid HIV Test for detection of HIV antibodies
in human serum or plasma. The new MedMira(TM) Rapid HIV Test will
be made available immediately in Canadian clinical healthcare
settings. Health Canada's approval highlights the second major
regulatory approval of product enhancements that MedMira has
applied for, and successfully obtained this year. Production of
this new Canadian product will substantially increase MedMira's
operational efficiencies and further position the Company for
expansion into new applications. The new MedMira(TM) Rapid HIV Test
contains features similar to that approved by the United States
Food and Drug Administration (June, 2004) making it simpler to use
and offering substantial time and cost-savings to the user. The
most prominent enhancement of the new test includes an on-board
control line for validation of the test result. "MedMira strives to
meet and exceed market demands by improving products to reflect our
customer's needs", said Hermes Chan, President and Chief Operating
Officer of MedMira. "With these two recent North American approvals
for our highest quality products, we have proven that we can
anticipate the market needs, and have the resources to navigate
these important regulatory pathways in a timely manner. I want to
congratulate our regulatory team for such a great achievement." The
MedMira(TM) Rapid HIV Test provides test results in just under
3-minutes and is intended for clinical healthcare settings,
emergency situations, delivery rooms and occupational exposures. At
the end of 2003, there were approximately 56,000 adults and
children in Canada living with HIV/AIDS (with an adult prevalence
rate of 0.3%). According to 2004 UNAIDS statistics, approximately
3500 people are newly infected with HIV in Canada each year. About
MedMira MedMira is a leading global manufacturer and marketer of in
vitro rapid diagnostic tests for the clinical laboratory market.
MedMira's tests issue 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, hepatitis B and hepatitis C.
The United States Food and Drug Administration (FDA) and the State
Food and Drug Administration (SFDA), in the People's Republic of
China, have approved MedMira's Reveal(TM) G2 and MiraWell(TM) Rapid
HIV Tests, respectively. MedMira has the only rapid diagnostic
device to receive these two prominent government approvals. For
more details visit MedMira's website at http://www.medmira.com/.
MedMira's Reveal(TM) G2 and MiraWell(TM) rapid HIV tests are
currently used in clinical laboratories and hospitals where
professional counseling and patient treatment are immediately
available. MedMira markets its rapid tests worldwide in such
countries as the United States, Canada, South Africa and China. Its
corporate offices and manufacturing are located in Halifax, Nova
Scotia, Canada. This news release contains forward-looking
statements, which involves risks 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: MedMira Contact: Dr. James Smith,
(902) 450-1588 or e-mail:
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