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Gold/Mining/Energy : Medmira CDNX:MIR -- Ignore unavailable to you. Want to Upgrade?

To: zakaran who wrote (4)	4/19/2003 8:02:41 AM
From: John E.Quinn	Respond to of 5

MedMira obtains FDA approval for HIV-1 antibody test 2003-04-17 13:13 ET - News Release Dr. James Smith reports MEDMIRA RECEIVED FDA APPROVAL MedMira has disclosed that the United States Food and Drug Administration (FDA) has approved the company's Reveal Rapid HIV-1 antibody test, the first and only FDA-approved rapid, point-of-care test designed to detect HIV-1 antibodies within three minutes. The Reveal Rapid HIV-1 antibody test will be distributed exclusively to health care providers in the United States by Cardinal Health (NYSE: CAH), the leading provider of products and services supporting the health care industry. With the FDA approval, MedMira can market the Reveal Rapid HIV-1 antibody test for the detection of HIV-1 antibodies in serum or plasma. This test has a one-year shelf life at room temperature, the longest of any rapid HIV tests available in the United States. MedMira's test also produces highly accurate results substantially faster than any other FDA-approved HIV diagnostic test. It is designed for point-of-care diagnostic purposes in medical settings such as hospitals and clinics. MedMira's rapid test produces reliable results in three minutes, potentially eliminating the possibility of an HIV-carrier unknowingly infecting others. Results from the conventional HIV antibody screen tests (using the enzyme immunoassay) are generally not available for several days to a few weeks. "In addition to our recent approval by the SDA in the People's Republic of China, we have achieved another major strategic goal of gaining access to large markets where the power of our technology can be used to make a difference in a significant public health campaign," said Stephen Sham, chairman and chief executive officer of MedMira. "We are very pleased to enter the United States market with the best rapid HIV test to date. Many countries view the approval to market a diagnostic test by the FDA to be the gold standard of endorsement. Now that we have obtained this approval, we are very optimistic about the immediate expansion of MedMira's operations. We look forward to fulfilling the global diagnostic marketplace with our unique diagnostic products." Mr. Sham added that Cardinal Health was chosen as MedMira's distributor based on its proven ability to meet the needs of U.S. health care providers. "By working with Cardinal Health, we are confident that all health care providers will have full access to this much-needed test," Mr. Sham said. WARNING: The company relies upon litigation protection for "forward-looking" statements.