CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (NASDAQ:CERS) announced today that it has submitted a clinical protocol to the U.S. Food and Drug Administration (FDA) 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. The Treatment Use provision allows the FDA to grant early access to a medical treatment not yet approved in the US when no satisfactory alternative is available to treat patients with serious or life-threatening conditions. The protocol submitted by Cerus is designed to allow blood banks and hospitals in geographies threatened by transfusion-transmitted Chikungunya and dengue the earliest possible access to the INTERCEPT treatment of platelet components. The INTERCEPT platelet system license application is under FDA review, with an approval decision expected in 2015. The INTERCEPT system has been approved for use in Europe for 12 years and is used in over 100 blood centers outside the US.
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