FDA Approves Candian Biotech Firm’s Rapid HIV Test
Halifax, Canada-based biotechnology company MedMira announced last week that the FDA has approved the company's three-minute HIV antibody testing kit, the Hamilton Spectator reports. The company plans to begin distributing the test, which costs the company about $2.25 to manufacture, in the U.S. market. According to a company spokesperson, MedMira will have an order from the United States for 500,000 rapid-detection test kits (Tutton, Hamilton Spectator, 4/21). The company is already rushing to manufacture 250,000 of the HIV tests to distribute to health clinics in China, where the test was approved earlier this month. Health Canada approved the test in 1998 (Kaiser Daily HIV/AIDS Report, 4/14). Jim Smith, vice president of corporate affairs for MedMira, said that U.S. approval has taken six years, adding, "About 80% of companies don't make it through this process and end up failing" (Hamilton Spectator, 4/21). MedMira President and CEO Stephen Sham said, "We are very pleased to enter the United States market with the best rapid HIV test to date. Many counries view the approval to market a dignostic test by the FDA to be the gold standard of endorsement" (MedMira release, 4/17).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.