Intercept Blood System for plasma regulatory update

Cerus submitted to FDA a clinical protocol to make the company's Intercept Blood System available under a compassionate use investigational device exemption (IDE) for treatment of convalescent plasma collected from Ebola survivors for passive immune therapy. Cerus said the World Health Organization (WHO) identified convalescent plasma as a potential therapy for Ebola infection. The company said a compassionate use IDE allows U.S. patients with serious or life-threatening conditions access to an unapproved product if the treating physician believes it may provide a benefit.

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. ...