Cerus Corporation (NASDAQ:CERS) announced that the U.S. Food and Drug Administration (FDA) has issued a revised draft guidance document that aims to provide blood centers with sufficient recommendation on how to control the risk of bacterial contamination of platelets. Pathogen reduction technology has been included as a recommended method of reducing the risk of transfusion-transmitted sepsis. The document is titled ‘Bacterial Risk Control Strategies for Blood Collection Establishment and Transfusion Services to Enhance the Safety and Availability of Platelet for Transfusion.
According to the document, the risk of bacterial contamination in platelet unit is higher than in other blood components. The risk is high because of platelet need of being stored at room temperature. Dr. Richard Benjamin, chief medical officer of Cerus , noted that despite screening interventions that were introduced, platelet transfusion is still high at a rate of 1 in 1000. By revising the bacterial standard, the FDA is making a strong statement that there is a need to protect patients from septic transfusion reaction.
The draft recommended that platelet component must either be tested for bacteria or undergo treatment through the pathogen reduction technology. When testing is used to ensure bacterial safety, it must include an early culture test at less than 24 hours after the collection and a subsequent test for any platelet units that are stored for four to five days. When pathogen reduction is used, there is no need for preventive testing.
Intercept Blood System is the currently the only FDA-approved pathogen reduction technology as of now.
Carol Moore, who is Cerus’ senior vice president of regulatory affairs and quality, noted that the inclusion of a pathogen reduction option gives blood centers the chance of eliminating early bacterial culture test, allowing the release of platelet components to hospitals sooner. Also, hospitals avoid changing their operational procedures to include subsequent testing.