http://www.nytimes.com/2014/12/17/business/fda-approves-system-that-may-make-blood-transfusions-safer.html 2014-12-17 03:16:00 F.D.A. Approves System That May Make Blood Transfusions Safer The system is being used in clinical trials in West Africa to make plasma donated by Ebola survivors safer to use as a possible treatment. === The The system represents an extra safety step beyond testing donations for viruses like “You can’t test for something unless you know what it is,” said William M. Greenman, the chief executive of The product is being used in a clinical trial in West Africa to make plasma donated by Some experts in blood transfusions said, however, that it was far from clear that Intercept would be widely used in the United States, where the blood supply is already deemed safe. Testing of donated blood for various viruses will continue, they said, so the Intercept treatment would represent an additional cost. “The nonprofit blood collection industry can’t afford it,” said Dr. Michael P. Busch, director of the nonprofit Blood Systems Research Institute and a professor at the University of California, San Francisco. “Blood is extraordinarily safe now.” Mr. Greenman said the company’s treatment would add about $30 to the approximately $60 cost of obtaining and testing a unit of plasma, the liquid component of blood. Cerus also hopes to receive approval soon to treat platelets, which cause blood to clot. He said Intercept would add about $50 to the roughly $500 cost of a unit of platelets, which are prone to bacterial contamination. Approval for red blood cells, which carry oxygen in the bloodstream and account for most transfusions, remains years away. The system involves adding a chemical to the plasma or platelets and then exposing them to ultraviolet light. The light causes the chemical to bind to any DNA or RNA in the sample, rendering bacteria, viruses or other pathogens unable to replicate. The plasma and platelets do not need RNA or DNA to function, so they are not harmed, at least in theory. The F.D.A. cautioned that the system was not foolproof. While the system works well against H.I.V., Dr. Walter Dzik, co-director of the transfusion service at Massachusetts General Hospital, said there was some concern that “in the process of killing the germs, you may damage the platelets as well.” There have also been concerns about the safety of the chemical used to treat the blood. Mr. Greenman of Cerus said there was a slight loss of platelets during the process, but that was minor. He said that the system had proved safe in Europe, where it was approved several years ago. Cerus reported revenues of $26.8 million in the first nine months of the year but still lost $18.6 million. The company’s stock rose 20 percent in after-hours trading Tuesday, after the F.D.A. announcement. Products like immune globulin and clotting factors that are made in factories from pooled plasma donations have long been subject to pathogen inactivation treatment. But Intercept is the first approved process that blood banks will perform themselves. Some experts said the system might be most useful in areas without safe blood supplies. In West Africa, a trial has just started testing blood from Ebola survivors as a treatment for those still battling the disease. The so-called convalescent plasma is presumed to contain But those survivors might have other diseases like The system is now also being used at Emory University to treat plasma donations from Ebola survivors, Mr. Greenman said. He said it would be used to treat platelet donations in Puerto Rico, where blood banks were trying to cope with the dengue and chikungunya viruses. Cerus, based in Concord, Calif., was started in 1991 after one of its founders, a hematologist, noticed that patients with “This is a story about perseverance,” Mr. Greenman said. “It’s an emotional time for the company.”