Intercept Blood System for platelets regulatory update

Cerus said FDA accepted a clinical protocol to make the company's Intercept Blood System for platelets available under an expanded access investigational device exemption (IDE) for use in regions in the U.S. with outbreaks of Chikungunya and dengue virus. As of Sept. 30, the Centers for Disease Control and Prevention (CDC) reported 11 confirmed cases of Chikungunya in Florida, 421 cases in Puerto Rico and 45 cases in the U.S. Virgin Islands, as well as cases of dengue in Texas and Florida.

PMAs for the Intercept Blood System for platelets and for plasma are under FDA review. The Intercept Blood System, which uses light-activated molecules to crosslink DNA and RNA to prevent pathogen replication, already has CE Mark approval for platelets and plasma. Cerus markets the system in Europe, the Commonwealth of Independent States (CIS) and the Middle East to inactivate blood-borne pathogens in donated blood components intended for transfusion. ...