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FDA Exemption Sought for Ebola Blood Plasma Device

Scanning electron micrograph of Ebola virus

Scanning electron micrograph of Ebola virus (National Institute of Allergy and Infectious Diseases)

20 October 2014. Cerus Corp., a developer of blood safety devices, is asking the U.S. Food and Drug Administration to allow its system for removing pathogens from blood plasma be used to treat patients in the U.S. with Ebola, while the device is under review. The provision, called a Compassionate Use Investigational Device Exemption, allows physicians to allow the use of medical devices still under review in cases of serious or life-threatening conditions, and where no other alternatives are available.

Plasma is the part of blood containing proteins for blood clotting and antibodies to fight infections. Processes for donating plasma separate the plasma from blood, then return the remaining red blood cells to the donor’s blood stream. Plasma can be frozen and kept for up to a year.

The Concord, California company’s Intercept system for plasma synthesizes psoralen, a natural substance, into a compound known as amotosalen that penetrates DNA and RNA of targeted pathogens in plasma. When exposed to ultraviolet light, amotosalen forms a chemical cross-link with the genetic material, preventing it from replicating, thus deactivating the pathogen and preventing disease. Another Cerus system works the same way with blood platelets.

Because blood from Ebola victims contains antibodies against the disease, public health authorities are considering transfusions from Ebola patients who survived — now about half of those who contract the disease — as a therapy. Anecdotal evidence from previous Ebola outbreaks in Africa going back to 1976 show transfusions of whole blood or plasma help some patients recover. Kent Brantly, an American physician who contracted Ebola in Liberia and survived, received a whole-blood transfusion from another survivor, and in turn provided his plasma to three other patients.

One risk of blood or plasma transfusions is the presence of other pathogens that can cause other serious conditions, such as HIV or malaria, for Ebola patients. Cerus says its Intercept system can remove those pathogens, thus ensuring a safer supply of plasma for therapeutic transfusions.

The Intercept system is already approved for use in Europe and now under review by FDA. The company says a decision by FDA is expected in 2015.

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