AEGiS-PRn: MedMira Receives "Review Complete" Notification from U.S. Food and Drug Administration for Reveal(TM) HIV Test

Important note: Information in this article was accurate in 2001. The state of the art may have changed since the publication date.

MedMira Receives "Review Complete" Notification from U.S. Food and Drug Administration for Reveal(TM) HIV Test

PRNewswire - December 27, 2001

HALIFAX, NS, Dec. 27 /PRNewswire/ - MedMira announced today that it has received official notification from the U.S. Food and Drug Administration ("FDA") that it has completed its review on the Pre-Market Approval application for the MedMira Reveal(TM) HIV Test. The FDA has no further questions in relation to the pre-clinical and clinical information that was submitted as part of the application. The next phase of the approval process will be the onsite "current Good Manufacturing Practices" inspection which is anticipated to occur early in 2002.

"Needless to say, we are delighted to have made it over this hurdle in the application process" stated Stephen Sham, Chairman and CEO of MedMira. "We have been working very hard and very closely with U.S. consultants and the FDA over the past few months to ensure all questions posed by the FDA were answered in a timely manner. Our plan for 2002 is to continue that collaboration so that we will be properly prepared for the upcoming manufacturing inspection."

The MedMira Reveal(TM) HIV Test is a rapid test that detects the antibodies to HIV in serum or plasma, but unlike standard lab based tests that may take weeks for results to be obtained, the rapid test can provide results in 3 minutes.

MedMira is a publicly traded (CDNX:MIR), ISO 9001 registered Canadian medical biotechnology company that develops, manufactures and markets a new generation of "easy to use" rapid diagnostic tests and instrumentation to aid in the diagnosis of both infectious and non-infectious human disease.

This news release contains forward-looking statements that reflect the company's current expectation regarding future events. The forward-looking statements involve risk and uncertainties. Actual events could differ materially 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's quarterly filings.

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