Bethesda, Md. – AABB today applauded the U.S. Department of Health and Human Services’ plan to spend up to $330 million to advance development of pathogen reduction technologies that could protect the nation’s blood supply from bacteria, parasites, Zika and many other viruses, and other pathogens.
Last month the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) announced that the Biomedical Advanced Research and Development Authority (BARDA), had committed up to $180.5 million to Cerus Corporation of Concord, California to advance its INTERCEPT system for the treatment of red blood cells; and up to $169.3 million to Terumo BCT Technologies of Lakewood, Colorado to further develop its Mirasol system for platelets.
“BARDA’s announcement demonstrates the seriousness of infectious diseases like Zika, dengue, and chikungunya viruses,” said Miriam Markowitz, CEO of AABB. “This funding and the willingness of our health agencies to advance new technologies could result in a whole new and systemic way to combat transfusion-transmitted infections.”
Currently, all blood undergoes two different screening tests to detect many pathogens: serologic (antibody) tests and Nucleic Acid Tests (NAT). If the pathogen reduction process proves effective for removing impurities, it could change how blood is screened, and even who can donate.
Under the BARDA agreement, Terumo BCT Technologies will conduct a clinical trial to confirm the Mirasol system’s ability to reduce the risk of infection in platelets. The contract could be extended for additional nonclinical studies, clinical studies, manufacturing and next-generation product development, including expansion of the Mirasol system.
Cerus will evaluate the safety of the blood system in Puerto Rico, conducting clinical trials of the company’s INTERCEPT system for red blood cells. The agreement can be extended for up to five years for additional clinical studies, manufacturing, and next-generation product development as needed, including additional testing of the INTERCEPT system in Zika-virus epidemic regions.
A different version of the INTERCEPT blood system already has been approved by the Food and Drug Administration for reducing the risk of infection through the transfusion of platelets and plasma.
BARDA is charged with advancing new medical products to protect the nation’s health from emerging infectious diseases or chemical, biological, radiological, or nuclear (CBRN) threats, particularly for radiological or nuclear mass casualty incidents requiring the use of blood products.
According to the HHS press release, pathogen reduction technologies, which reduce the presence of infectious viruses, bacteria, and other pathogens, can provide an additional layer of safety for blood products in the US. In particular, the technologies can reduce the risk of transmitting emerging infectious diseases for which robust screening and testing methods may not yet be available.
AABB is an international, not-for-profit association representing individuals and institutions involved in the fields of transfusion medicine and cellular therapies. The association is committed to improving health through the development and delivery of standards, accreditation and educational programs that focus on optimizing patient and donor care and safety. AABB membership includes physicians, nurses, scientists, researchers, administrators, medical technologists and other health care providers. AABB members are located in more than 80 countries and AABB accredits institutions in over 50 countries. For more information, visit www.aabb.org.