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."
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."
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