Cerus Corporation (NASDAQ:CERS) announced today that the German National Blood Advisory Committee, or the AK Blut, has advised the German Ministry of Health that the shelf-life of conventional platelet components should be shortened to four days to reduce the incidence of life-threatening septic transfusion reactions arising from potential bacterial contamination. Only pathogen-inactivated platelets, such as those treated with the INTERCEPT Blood System, are exempt from the new restriction and may be stored for five days. Cerus is working with blood centers in Germany to implement the INTERCEPT Blood System and is supporting their individual regulatory applications for sale of INTERCEPT-treated platelets.
“We commend the AK Blut for its strong commitment to improving transfusion recipient safety and appreciate its recognition that INTERCEPT has demonstrated efficacy against a broad range of bacteria that may contaminate donated platelets and cause serious septic reactions,” said Dr. Laurence Corash, senior vice president and chief medical officer of Cerus. “We believe that using the INTERCEPT platelet system allows blood banks to offer safer platelets to transfusion patients, while improving platelet supply.”
Supporting documentation released with the AK Blut advisory statement indicates that their recommendation considered both bacterial transfusion safety risk and available measures for risk mitigation. In the period from 1997 to 2007, 145 suspected clinical cases of bacterial infection due to blood components were reported in Germany, including five fatal cases attributed to platelet transfusion. The committee concluded that platelets have the highest rate of transfusion-related septic risk compared to other blood components.
Potential use of bacterial culture detection, a technology used in other countries to reduce bacterial risk, was assessed on the basis of published studies from Canada, the Netherlands, Norway, the United States and Germany that analyzed results from over 1.4 million tested platelet units. The committee noted that false negative results were an inherent weakness of the culture detection approach, with the data demonstrating that transfusion-related fatalities cannot be prevented. Therefore, the AK Blut recommended that conventionally prepared platelets be stored for a maximum of four days – down from five days – based on the association between risk of fatality and age of the platelets transfused. Pathogen inactivation was also considered as a risk mitigation strategy for bacterial contamination, with evaluation of INTERCEPT treatment’s efficacy against relevant pathogens leading to an exemption from the new four-day storage limit.
ABOUT AK BLUT
AK Blut advises the federal government in matters of safety and availability of blood and blood products. Members include representatives of the German Federal Chamber of Physicians, the German Red Cross, the Medical Council of Federal and Communal Blood Transfusion Services, the Federal Ministry of Defense, relevant scientific societies, the pharmaceutical industry, local governments, and patient groups. In addition, representatives of the Federal Ministry for Health and Social Security, the Federal Institute for Drugs and Medical Devices, as well as the Paul Ehrlich-Institute each have permanent membership on the committee.
ABOUT THE INTERCEPT BLOOD SYSTEM
The INTERCEPT Blood System is designed to reduce the risk of transfusion-transmitted diseases by inactivating a broad range of known and emerging pathogens, including viruses, bacteria and parasites, as well as harmful white blood cells that may be present in donated blood intended for transfusion. The system inactivates pathogens in platelets and plasma using a proprietary illumination device, process and active compound. The INTERCEPT Blood System is designed to be easily incorporated into the typical operations of blood banks, and treated platelets are approved for storage up to seven days according to local guidelines. The INTERCEPT Blood System has received CE mark approvals for both the platelet and plasma systems. More than 200,000 INTERCEPT Blood System disposable kits have been shipped to date to more than 60 sites in 20 countries. For more information on the INTERCEPT Blood System visit www.interceptbloodsystem.com.
Cerus Corporation is a biomedical products company focused on commercializing the INTERCEPT Blood System to enhance blood safety. Cerus currently markets the INTERCEPT Blood System for both platelets and plasma in Europe, Russia, the Middle East and selected countries in other regions around the world. The company is also pursuing regulatory approvals in the United States and other countries. The INTERCEPT red blood cell system is currently in clinical development.
INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.
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