April 10, 2003
The test, which costs about US$2.25 to manufacture, measures the level of antibodies in the blood to determine a person's HIV status. Similar to home pregnancy kits, the rapid HIV test shows two red lines for a positive result. Unlike conventional HIV tests that can take several weeks to give results, MedMira's test produces results in about three minutes. In China, the tests will only be distributed to clinics and hospitals.
Stephen Sham, chair and CEO of MedMira, called the approval a landmark event for his company, which was founded in a university basement several years ago. "This regulatory approval achieves one of the company's strategic goals 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 Sham.
Chinese HIV infection rates have surged, particularly in remote regions where IV drug use, prostitution, migration and blood transfusions have increased. In addition, China's blood supply was largely unregulated in the 1980s and many private agencies mixed supplies, reused needles and operated without sterilized equipment.
MedMira -- which also manufactures diagnostic tests to detect hepatitis -- signed a deal last month to supply 1 million tests to the Democratic Republic of Congo. Currently, the company awaits approval from the Food and Drug Administration for distribution in the United States. Health Canada approved the test in 1998.