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 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.
SOURCE MEDMIRA INC.