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in how blood centers think about keeping their supplies safe. The traditional model is to test for something specific you think might be there, like HIV or West Nile virus. The Intercept system is designed to inactivate all known or unknown pathogens by interfering with DNA and RNA so the virus can’t replicate. While there are ways to kill known pathogens like HIV, there are always new pathogens being identified every year that require new strategies to get rid of, Glassell says. The Cerus argument is that by using its technology, blood centers will have security knowing that they are already wiping out pathogens that haven’t even been identified yet as threats.
The study being presented at the NIH’s workshop on XMRV was only conducted on a blood sample from a single infected patient. Variability from patient to patient shouldn’t be an issue for this technology because of the broad mechanism it uses to interfere with viral replication, says Lainie Corten, Cerus’ director of global communications.
But it’s still just a small study offering a glimpse into where Cerus is going with this. The company is in talks with the FDA about the design of a pivotal Phase III clinical trial in the future that might provide evidence necessary to bring this to the U.S. market. The latest findings on XMRV and its possible link to chronic fatigue, combined with Cerus’ ability to wipe it out, will definitely give the company a potent new angle to talk about with the FDA in those negotiations.
While the FDA has traditionally said the U.S. blood supply is safe and doesn’t really need a sweeping new technology to protect it like the one from Cerus, the new evidence could sway regulators to reconsider. If that happens, Glassell says, “we could be in a very good position.”
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