Cerus has struggled for years to convince regulators that its technology for ridding the nation’s blood supply of pathogens deserves a chance on the U.S. market. Now the Concord, CA-based biotech company is pinning some renewed hope for its business on a study that says it can wipe out a newly discovered virus that some scientists suspect may the culprit behind the poorly understood disease known as chronic fatigue syndrome.
Cerus (NASDAQ: [[ticker:CERS]]), along with collaborators at the Whittemore Peterson Institute for Neuro-Immune Disease, are reporting today that the Cerus Intercept Blood System was able to wipe out all viable copies of a virus known as XMRV in the blood of an infected patient who had chronic fatigue syndrome. The findings are being presented today at the first International Workshop on XMRV being held at the National Institutes of Health in Bethesda, MD.
The result is bound to stir interest among the many active patients online, and researchers, who have spent years trying to better define this malady and find out what causes it. Many scientists have been looking to find a virus that might be the cause, and a study published last month in the Proceedings of the National Academy of Sciences offered a provocative suggestion that XMRV could be involved. That study, by NIH and FDA scientists, found that 86 percent of blood samples from chronic fatigue syndrome patients had the virus, while it was present in just 6.8 percent of healthy samples.
The Cerus technology is designed to kill all kinds of known and unknown pathogens. So that means the company is hopeful that if XMRV is branded as a lurking threat in the nation’s blood supply contributing to chronic fatigue syndrome, then it might have a new justification for why its technology should be approved for sale in the U.S. market. The Cerus technology is already available for sale in the European Union, and CEO Claes Glassell is counting on this to provide his company with a lift in sales.
“We think this study could potentially accelerate our rate of adoption in Europe,” Glassell says. “It’s a new threat to blood safety, and a lot of people in Europe are wondering about how to address it.”
If this is the big new pathogen for Cerus, it will have been a long time coming. The company was founded in 1993, won clearance to sell its system in Europe in 2002, but has never been able to persuade the FDA that its technology was needed to protect the U.S. blood supply. Cerus, with about 73 employees today, has racked up an accumulated deficit of $420 million and has never been consistently profitable, according to its most recent quarterly report. It has taken years to gain acceptance for its technology, and Cerus has only captured about 4 percent of the total available market it sees in Europe, but acceptance is gaining, Glassell says. Based on sales growth rates of the first half of 2010, Cerus expects to generate $21 million to $22 million in sales this year, and it figures it can reach break-even when it reaches about $50 million in annual sales, Glassell says.
The Intercept system represents a pretty big shift
