The US Food and Drug Administration (FDA) has authorized the use of a pathogen inactivation system in regions of the US and its territories affected by outbreaks of Chikungunya and dengue virus.
The INTERCEPT Blood System for platelets is used for the preparation and storage of whole blood-derived and apheresis platelets.
The system can inactivate a range of viruses, bacteria, and parasites to reduce the risk of transmission via platelet transfusion. It can also prevent transfusion-associated graft-vs-host disease and reduce the risk of other adverse effects due to transfusion of contaminating donor leukocytes.
The INTERCEPT Blood System for platelets has not been granted full FDA approval. The agency has approved use of the system via an investigational device exemption (IDE).
This allows for early access to a device not yet approved in the US when no satisfactory alternative is available to treat patients with serious or life-threatening conditions.
The INTERCEPT Blood System for platelets will initially be available to sites in Puerto Rico that agree to participate in a clinical study. Depending on the scope of participation there, the system may be made available to sites in other areas where cases of Chikungunya and dengue have been reported, such as Florida and Texas.
“We are pleased to provide US blood centers and hospitals early access to INTERCEPT for the treatment of platelet components in light of the escalating threat of Chikungunya and dengue transfusion-transmitted infections,” said Carol Moore, of Cerus Corporation, the company developing the INTERCEPT system.
“With this expeditious approval of our IDE, we hope to initiate our first study site before year-end.”
About the system
The INTERCEPT Blood System for platelets is based on the premise that platelets don’t require functional DNA or RNA, but pathogens and contaminating leukocytes do. The system deploys proprietary molecules that, when activated, bind to and block the replication of DNA and RNA in the blood.
The system uses amotosalen HCl (a photoactive compound) and long-wavelength ultraviolet illumination to photochemically treat platelet components, rendering susceptible pathogens incapable of replicating and causing disease.
Published studies have demonstrated INTERCEPT inactivation of >6.4 log of Chikungunya and >5.3 log of dengue infectious titers, both in excess of observed titers in asymptomatic donors.
The INTERCEPT platelet system has been approved in Europe since 2002 and is currently used at more than 100 blood centers in 20 countries. The system is under regulatory review in the US, Canada, Brazil, and China.
About dengue and Chikungunya
Dengue virus is endemic to the Caribbean region. Local transmission of Chikungunya virus was detected in the Caribbean for the first time in February 2014. Both viruses are spread by species of mosquitoes common in tropical climates and regions within the continental US.
As of September 30, 2014, the Centers for Disease Control and Prevention has reported 11 confirmed locally transmitted cases of Chikungunya in
Florida, 421 cases in Puerto Rico, and 45 cases in the US Virgin Islands. Local transmission of dengue has also been reported in Texas and Florida.
Chikungunya virus causes high fevers, joint pain and swelling, headaches, and a rash. Symptoms have been reported to persist for up to 2 years in chronic cases. Rarely, Chikungunya can be fatal.
Symptoms of dengue include high fever, headaches, joint and muscle pain, vomiting, and a rash. In some cases, dengue infection is life-threatening due to dengue hemorrhagic fever, which causes bleeding from the nose, gums, or under the skin.
