Seeking a Killer
When Doctors Can't Wait
The test is being studied in two separate trials, one at Boston University Medical Center and one at the University of Massachusetts Medical Center. If all goes well, Holzer hopes to submit the results of these studies to the U.S. Food and Drug Administration by the end of 2001. If the FDA approves the test, the earliest it could be available commercially would be mid-2002.
Results for the new test so far have been very promising, says Alan Michelson, MD, professor of pediatrics and pathology at the University of Massachusetts Medical School. "A test that could rapidly tell you whether or not an infant is septic would save families a lot of trauma and a lot of money," says Michelson, who isn't directly involved in the trials of the sepsis test, but does other research involving CompuCyte. "There are a lot of babies who wouldn't need intensive care treatment."
Naomi Williams couldn't agree more. After eight days of anguish -- some spent sleeping in an unused recovery room in the hospital, some at home without her newborn son -- she came closer to a breakdown than she'd ever thought possible. At last, the couple was able to bring home a vigorous, healthy Julian. But they still don't know if he ever had sepsis. Williams is grateful to the hospital for the care they provided, and she knows it may well have saved her son's life. Still, "this was the most traumatic experience of our lives. But was it really necessary?" she wonders. "Wouldn't it be great if you could find out sooner?"
"Everybody's still looking for the magic wand," says Charles R. Rosenfeld, MD, director of the Division of Neonatal-Perinatal Medicine at the University of Texas Southwestern Medical Center in Dallas. "It must permit you to have very high specificity -- that is, few false negatives -- and very high sensitivity, which would be few false positives." While not familiar with the CompuCyte test, Rosenfeld cautions that even with a 20-minute result, physicians still will be inclined to begin treatment immediately. "You're still going to end up treating these kids in the first 24 hours. Nobody in his right mind is going to wait for a test to come back -- no matter how quickly -- if you think the baby's infected," he says.