Cerus secures FDA approval for Intercept blood plasma system

17 December 2014 (Last Updated December 17th, 2014 18:30)

The US Food and Drug Administration (FDA) has granted approval for Cerus's INTERCEPT Blood System, which is indicated to reduce the risk of transfusion transmitted infections (TTI) from plasma components.

The US Food and Drug Administration (FDA) has granted approval for Cerus's INTERCEPT Blood System, which is indicated to reduce the risk of transfusion transmitted infections (TTI) from plasma components.

The system is approved for ex-vivo preparation of plasma, which will help reduce the risk of TTI when treating patients requiring therapeutic plasma transfusion.

It has the capacity to inactivate a broad spectrum of enveloped viruses, non-enveloped viruses, gram-positive and gram-negative bacteria, spirochetes and parasites.

For a limited number of pathogens, existing screening tests lowered the risks from transfusion transmitted infections.

"The system is approved for ex-vivo preparation of plasma, which will help reduce the risk of TTI when treating patients requiring therapeutic plasma transfusion."

These tests are reactive approaches, requiring identification of specific pathogens for which tests can be developed and implemented.

In Europe, INTERCEPT pathogen reduction was used for more than ten years as a safety option for platelet and plasma components, and it was recently made available in the US under two investigational device exemption (IDE) trials.

In the first trial, the system processed platelets will be used to reduce the risk of transfusion transmitted dengue and chikungunya viruses. Both are responsible for current epidemics in the Caribbean region, including Puerto Rico, as well as cases reported in the south of the US.

The system is being used in the second trial to prepare Ebola convalescent plasma for passive immune transfusion therapy of acutely infected patients, providing an additional layer of safety against pathogens that recovered donors may have been exposed to due through recent travel in Africa.

Plasma from recovered Ebola virus patients treated with the INTERCEPT process will be used to develop a national stockpile for future patients.

American Red Cross Biomedical Services scientific affairs vice-president Dr Susan Stramer said: "Plasma transfusions are an essential therapeutic treatment for many patients.

"Pathogens for which there are no available screening tests continue to emerge or re-emerge in the population due to increases in travel, immigration and climate change, thus potentially increasing risk of transmission to patients and impacting donor availability."

The system includes single-use plasma processing sets and an ultraviolet (UVA) illumination device for the ex-vivo preparation and storage of pathogen-reduced, whole blood-derived or apheresis plasma.

The company said safety and efficacy of plasma prepared with the system was evaluated in six clinical studies including a total of more than 500 patients.