AEGiS-WSJ: Cerus, Baxter Win EU Approval For Blood-Cleansing System Wall Street JournalImportant note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.
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Cerus, Baxter Win EU Approval For Blood-Cleansing System

Wall Street Journal - June 4, 2002
Vanessa Fuhrmans, Staff Reporter of The Wall Street Journal


Cerus Corp. and Baxter International Inc. won European regulatory approval for a system that rids blood platelets of nearly all pathogens, a process that could usher in a new level of safety to blood transfusions.

Blood-safety experts say the process, which uses an ultraviolet light to trigger a chemical reaction that attacks the genetic makeup of the germs, could eliminate rare transmissions of HIV, hepatitis and other viral infections through transfusions not caught by other screening measures.

Because it targets all viruses and bacteria, it also could kill bugs that haven't even been identified.

Though other companies are developing ways to inactivate blood-borne pathogens, Cerus and Baxter's Intercept Blood System, as the process is called, is the first to win a major regulatory approval. The two companies expect to secure separate European regulatory approval for the illumination device that accompanies the system in August and launch it on the European market in the fourth quarter.

Roughly 1.3 million platelet transfusions are performed annually in Europe to prevent bleeding in patients undergoing high-dose chemotherapy, heart-bypass surgery or other operations.

Cerus and Baxter hope to win U.S. approval to use the system to screen blood platelets by early next year and for plasma, another blood component, later in 2003. Eventually, the companies hope to gain approval and market the system as a treatment for red blood cells, which account for about 14 million to 15 million transfusions each year in the U.S. alone and represent the bulk of the multi-billion dollar global blood-testing market.

Some analysts estimate that the market for blood pathogen inactivating processes could exceed $3 billion if they become a blood safety standard in hospitals and blood-collecting centers world-wide. But other experts say that success will depend on how willing insurance companies and other health-care providers are to take on the additional cost for purified blood components when so many other tests are available to ensure safety.

One new test, for instance, reduces the chance of an HIV or hepatitis C transmission through a blood transfusion to about one in two million.

Although the technology eliminates pathogens, it can't attack prions, the mutated proteins that cause mad-cow disease, the companies said.

Write to Vanessa Fuhrmans at vanessa.fuhrmans@wsj.com


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