CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (NASDAQ:CERS) announced today that the U.S. Food and Drug Administration (FDA) has accepted Cerus’ clinical protocol to make the INTERCEPT Blood System for platelets available under an Expanded Access Investigational Device Exemption (IDE) to regions in the United States with outbreaks of Chikungunya and dengue virus.
Dengue virus is endemic to the Caribbean region. Local transmission of Chikungunya virus was detected in the Caribbean for the first time in February of 2014. Both viruses are spread by species of mosquitoes common in tropical climates as well as regions within the continental U.S. Chikungunya virus causes high fevers, joint pain and swelling, headaches and a rash. Symptoms have been reported to persist for up to 2 years in chronic cases. Rarely, Chikungunya can be fatal.1 Symptoms of dengue include high fever, headaches, joint and muscle pain, vomiting, and a rash. In some cases, dengue infection is life threatening due to dengue hemorrhagic fever, which causes bleeding from the nose, gums, or under the skin. It can result in cause dengue shock syndrome, with massive bleeding.2 As of September 30, 2014, the Centers for Disease Control and Prevention (CDC) has reported 11 confirmed locally transmitted cases of Chikungunya in Florida, 421 cases in Puerto Rico and 45 cases in the U.S. Virgin Islands. Local transmission of dengue has also been reported in Texas and Florida.
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