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Published on 3/8/2006 in the Prospect News Biotech Daily.

MedMira president to discuss home-use HIV test at FDA meeting

By Lisa Kerner

Erie, Pa., March 8 - MedMira Inc. will publicly discuss its solution for over-the-counter home-use HIV tests at the Food and Drug Administration's Blood Products Advisory Committee (BPAC) meeting on Friday in Gaithersburg, Md.

The BPAC reviews and evaluates data concerning the safety, effectiveness and appropriate use of blood products derived from blood and serum, according to a company news release. It also reviews biotechnology intended for use in the diagnosis, prevention or treatment of human diseases.

The BPAC advises the Commissioner of Food and Drugs of its findings, as well as on the affirmation or revocation of biological product licenses.

"We believe that home HIV tests can bring many benefits to both consumers and public health agencies in the United States," president and chief operation officer Hermes Chan said in the release.

"More people will know their HIV status, seek treatment sooner, and ultimately decrease the spread of HIV."

MedMira's Reveal G2 and MiraWell rapid HIV tests are used in clinical laboratories, hospitals and clinics where counseling and treatment are immediately available, the release stated. The company's MiraCare Rapid HIV Antibody Test is available over-the-counter in pharmacies in Hong Kong, Macao Special Administrative Regions and the People's Republic of China.

MedMira, based in Halifax, N.S., manufactures and markets in vitro flow-through rapid diagnostic tests.


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