Cerus: FDA Accepts IDE Supplement For INTERCEPT Blood System In Ebola Plasma

(RTTNews) - Cerus Corp. (CERS) said the U.S. Food and Drug Administration has accepted its clinical protocol to make the INTERCEPT Blood System for plasma, available under an Investigational Device Exemption or IDE, for treatment of convalescent plasma collected from Ebola disease survivors for passive immune therapy.

Transfusion of blood or plasma from recovered Ebola patients may be of benefit in patients with acute Ebola infections. However, recovered patients may carry undetected pathogens due to previous exposure.

Emory University is equipped to collect Ebola convalescent plasma from recovered patients, and also to perform the INTERCEPT treatment onsite.

To further increase the availability of convalescent plasma, Cerus and the trial investigators are collaborating with the American Red Cross and America's Blood Centers to create a national network of plasma collection sites to access recovered Ebola patients.

Plasma collected from individuals who have recovered from Ebola virus disease contains antibodies against the virus.

Cerus said the IDE acceptance builds on support of INTERCEPT Blood System use for Ebola convalescent plasma in West Africa, which was recently announced by the Bill & Melinda Gates Foundation