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FDA OK's IDE for Cerus system for treating convalescent plasma for Ebola patients

Nov. 21, 2014 9:25 AM ETCerus Corporation (CERS) StockBy: Douglas W. House, SA News Editor1 Comment
  • The FDA accepts Cerus Corp.'s (NASDAQ:CERS) IDE supplement to make its Intercept Blood System for plasma available to treat convalescent plasma collected from Ebola survivors for passive immune therapy. Transfusion of blood or plasma from recovered Ebola patients may benefit those with acute Ebola infections, although the plasma may carry undetected pathogens due to prior exposure.
  • The trial will begin at Emory University Hospital and the University of Nebraska Medical Center. Emory is equipped to collect Ebola convalescent plasma from recovered patients and perform the Intercept treatment on site. After the CDC tests for Ebola antibodies, the treated plasma will be stored at Emory. It will also supply other Ebola treatment centers, such as the University of Nebraska, with the plasma.
  • In an effort to build the supply of convalescent plasma, Cerus and the trial investigators are working with the American Red Cross and America's Blood Centers to create a national network of plasma collection sites to access recovered Ebola patients.
  • The Bill & Melinda Gates Foundation recently made a $5.7M commitment to support efforts in Ebola-stricken African countries to scale up production and evaluation of potential Ebola therapies, including convalescent plasma treated with pathogen inactivation.
  • The Intercept System has been commercially available in Europe for eight years. It is currently under FDA review in the U.S.

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