Two pathogen reduction device technologies that may help reduce the risk of transmitting disease through blood product transfusions, including those diseases related to Zika virus, will advance in development with the support of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR).
The development of these technologies to treat red blood cells will be funded through contracts with ASPR’s Biomedical Advanced Research and Development Authority (BARDA) as part of BARDA’s ongoing efforts to advance 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.
“We are working to make needed products available as quickly as possible to protect our nation’s blood supply against a variety of threats that could endanger public health,” said Dr. Richard Hatchett, BARDA’s acting director. “These technologies are of particular interest given their potential use against multiple diseases. By focusing on products that can reduce the risk of various transfusion-transmitted infections, we can provide emergency products sooner in a sustainable, cost-effective way.”
Through a three-year, $30.8 million agreement, Cerus Corporation of Concord, Calif. will conduct clinical trials of the company’s INTERCEPT system for the treatment of red blood cells. This amount includes $10.7 million to contribute to the evaluation of safety of the blood system in Puerto Rico, made available to support the HHS response to the Zika virus outbreak. The contract may be extended for up to five years and $149.7 million to cover 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 also is partnering with Terumo BCT Technologies of Lakewood, Colo. to further develop the company’s Mirasol System. The two-and-a-half-year, $17.5 million agreement will support a clinical trial to confirm the system’s ability to reduce the risk of infection through platelets.
The contract may be extended up to a total of six years and $151.8 million for additional nonclinical studies, clinical studies, manufacturing and next-generation product development, including the expansion of the Mirasol system for use with plasma. BARDA also has the option to fund tests using the Mirasol system specifically against Zika virus.
Both systems have been shown to reduce the presence of certain bacteria, viruses and parasites in blood components, though to varying degrees.
These efforts complement other public health preparedness efforts of U.S. government partner agencies on blood safety, such as the HHS Office of the Assistant Secretary for Health, the Centers for Disease Control and Prevention, the National Institutes of Health, the U.S. Department of Defense, and the Food and Drug Administration.
The supply of blood products, which includes red blood cells, plasma, and platelets, is traditionally protected through a combination of safety measures. These methods include the preliminary screening of blood donors, the maintenance of deferred donor lists, the diversion of an initial aliquot of the collection, the testing of donated product for known diseases, and the quarantine of blood products until safety is established.
Pathogen reduction technologies, which reduce the presence of infectious viruses, bacteria, and parasites, can provide an additional layer of safety for blood products. 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.
The technologies also can reduce the risk of disease for blood product recipients from donor white blood cells and potentially have broad utility for use in emergency responses that require blood products, such as the detonation of an improvised nuclear device.