The US Food and Drug Administration (FDA) has approved Cerus Corporation's Intercept Blood System for plasma. The Intercept plasma system is approved for ex vivo preparation of plasma in order to reduce the risk of transfusion-transmitted infection (TTI) when treating patients requiring therapeutic plasma transfusion.
The Intercept Blood System inactivates a broad spectrum of enveloped viruses, non-enveloped viruses, Gram-positive and Gram-negative bacteria, spirochetes and parasites.
While current screening tests for a limited number of pathogens have lowered the risks from transfusion-transmitted infections, these tests are reactive approaches, requiring identification of specific pathogens for which tests can then be developed and implemented. In contrast, pathogen reduction by inactivation is a proactive safety measure-- the process can inactivate susceptible viruses, bacteria, and parasites present in plasma components independently of whether they have been identified as specific blood supply risks. This is critical because there is typically a lag between the emergence of new pathogens, and the recognition that an additional safety intervention may be needed.
"We believe this approval to be a pivotal step toward giving US blood centres a proactive approach for protecting the plasma supply," said William ‘Obi' Greenman, Cerus’ president and chief executive officer. "Cerus’ 22 year commitment to improving transfusion safety has been essential to achieving the US approval for Intercept plasma, and our continued work with FDA on reaching an approval decision for the Intercept Blood System for platelets."
As the recent chikungunya, dengue fever and Ebola outbreaks have demonstrated, pathogens continually emerge and present an ongoing threat to public health. 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 US 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, including Puerto 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.
"Plasma transfusions are an essential therapeutic treatment for many patients," said Dr. Susan Stramer, vice president, scientific affairs, Biomedical Services, American Red Cross. "Pathogens for which there are no available screening tests continue to emerge or reemerge in the population due to increases in travel, immigration and climate change, thus potentially increasing risk of transmission to patients and impacting donor availability. Pathogen reduction adds an additional layer of safety for our plasma supply.”
“We are pleased that we can now bring Intercept to the US where the idea for this technology was conceived, “ said Dr. Laurence Corash, chief medical officer and scientific officer of Cerus. “As a physician in San Francisco in the 1980’s we had to face our patients who had contracted HIV from transfusions of blood products. I am grateful to now be able to say to them that there is a proactive process to inactivate similarly virulent pathogens in the blood supply, even if we have not yet identified these newly emergent pathogens.”
Platelets, plasma and red blood cells do not require functional DNA or RNA for therapeutic efficacy. However, pathogens (bacteria, viruses and parasites) and white blood cells do require these nucleic acids in order to replicate. The Intercept Blood System targets this basic biological difference between the therapeutic components of blood, compared to harmful pathogens and donor white blood cells. The system uses a proprietary molecule that when activated, binds to and blocks the replication of DNA and RNA, preventing nucleic acid replication and rendering the pathogen inactive.