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OraSure Technologies, Inc. (Nasdaq:OSUR) today announced that the U.S. Food and Drug Administration (FDA) Blood Products Advisory Committee provided a unanimous positive recommendation for the Company's OraQuick® In-Home HIV Test. The BPAC provides advice to the FDA on issues related to the safety and effectiveness of biological products and medical devices seeking FDA approval.
"We are pleased with the outcome of today's Blood Products Advisory Committee meeting," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "There was broad support expressed by the HIV community at today's meeting and we look forward to continuing our work with them in the fight against HIV. We believe the OraQuick® In-Home HIV Test will make a valuable contribution in this fight."
According to the Centers for Disease Control and Prevention, despite current testing options, there are approximately 1.2 million people in the U.S. that have HIV and approximately 240,000 of them are unaware of their status. Those who do not know they are HIV positive are unknowingly responsible for up to 70 percent of the 50,000 new HIV infections that occur each year.
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