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HALIFAX -- MedMira Inc. announced today that Brown University, in conjunction with Walter Reed Army Institute of Research, has completed an independent sensitivity study of MedMira's Reveal Rapid HIV-1 Antibody Test. The results of this study indicated a sensitivity of 100 percent to all specimens collected from the one hundred HIV infected participants recruited from the Immunology Clinic of The Miriam Hospital. The Reveal Rapid HIV-1 Antibody Test has very recently received a Pre-Market Approval from the Food and Drug Administration (FDA).
"The Reveal Rapid HIV-1 Antibody Test is sensitive and easy to perform," said Dr. Michele Lally, the lead investigator at Brown University. "I believe that this test would be extremely useful to clinical laboratory settings across the United States."
"We are very pleased to have the opportunity to participate in this study," said Stephen Sham, chairman and CEO of MedMira. "The results of this study have once again affirmed the superior performance of our Reveal Rapid HIV-1 Antibody Test. A rapid HIV test with a long 12-month shelf-life at room temperature which provides results within three minutes, regardless of HIV status of the testing specimen, will certainly be an excellent tool to assist in fighting the recent uprising HIV cases in United States."
MedMira is a commercial biotechnology company that develops, manufactures and markets qualitative, in vitro diagnostic tests for the detection of antibodies to certain diseases, such as HIV, in human serum, plasma or whole blood. MedMira's Reveal and MiraWell Rapid HIV Tests have recently been approved by the United States FDA and SDA in the People's Republic of China, respectively. All of MedMira's diagnostic tests are based on the same flow-through technology platform thus facilitating the development of future products.
Source: MedMira Inc.