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FDA Approves New Enhancements in the Rapid HIV Test
May 10, 2005, 19:59, Reviewed by: Dr.
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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.
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By MedMira Inc.,
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. 
- U.S. Food and Drug Administration (FDA)
www.medmira.com
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 www.medmira.com.
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