Cerus Corporation out of Concord, California received FDA approval for its INTERCEPT Blood System for plasma, a product that’s used to prevent infections by treating blood plasma prior to a transfusion. The system relies on using a proprietary molecule to bind to the DNA and RNA of just about everything within the blood plasma sample. This molecule prevents the replication of nucleic acids, effectively deactivating viruses and bacteria that could be present.
The technique works because blood plasma, being empty of living cells, does not require DNA or RNA to be effective for transfusions. Because the system doesn’t target any specific pathogens but instead works on nearly all viruses and bacteria, there is no need for constant monitoring of relevant infections, having access to specialized assays, and having targeted compounds on hand to attack common pathogens. It’s already being used for the current Ebola outbreak and to stockpile plasma gathered from patients that have recovered from the disease.
INTERCEPT pathogen reduction has been used in Europe for over 10 years as a safety option for platelet and plasma components, and more recently was made available in the U.S. under two Investigational Device Exemption (IDE) studies. In the first study, INTERCEPT Blood System processed platelets will be used to reduce the risk of transfusion-transmitted dengue and chikungunya viruses, both of which are responsible for current epidemics in the Caribbean region, includingPuerto Rico, as well as cases reported in the Southern United States. In the second study, the INTERCEPT plasma system is being used to prepare Ebola convalescent plasma for passive immune transfusion therapy of acutely infected patients, providing an additional layer of safety against pathogens that these recovered donors may have been exposed to due recent travel in Africa. Plasma from recovered Ebola virus patients treated with the INTERCEPT process will be used to create a national stockpile for future patients.
Product page: INTERCEPT Plasma…
Press release: FDA APPROVES INTERCEPT BLOOD SYSTEM FOR PLASMA…