The US Food and Drug Administration (FDA) has approved the INTERCEPT Blood System for platelets, the first system of its kind to be approved in the US.
It is used to inactivate viruses, bacteria, spirochetes, parasites, and leukocytes in apheresis platelet components.
This can reduce the risk of transfusion-transmitted infection and, potentially, transfusion-associated graft-vs-host disease, although the system cannot inactivate all pathogens.
Certain non-enveloped viruses (such as HAV, HEV, B19, and poliovirus) and Bacillus cereus spores have demonstrated resistance to the INTERCEPT process.
Earlier this week, the FDA approved the INTERCEPT Blood System for plasma (also the first system of its kind to gain FDA approval).
The platelet and plasma systems use the same illumination device, the same active compound (amotosalen), and very similar production steps.
The INTERCEPT systems target a basic biological difference between the therapeutic components of blood. Platelets, plasma, and red blood cells do not require functional DNA or RNA for therapeutic efficacy. But pathogens and white blood cells do, in order to transmit infection.
The INTERCEPT systems use a proprietary molecule that, when activated by UVA light, binds to and blocks the replication of DNA and RNA, preventing nucleic acid replication and rendering the pathogen inactive.
The INTERCEPT Blood System for platelets has been approved in Europe since 2002 and is currently used in 20 countries.
The system was recently made available in the US and its territories under an investigational device exemption study to reduce the risk of transfusion-transmitted dengue and Chikungunya viruses, both of which are epidemic in the Caribbean region, including Puerto Rico, as well as sporadically in the southern US. No approved blood bank screening tests are available for either virus.
Researchers have evaluated INTERCEPT-processed platelets in 10 controlled clinical trials. Details on these trials can be found in the package insert.
