Seeking a Killer
When Doctors Can't Wait
Jan. 15, 2001 -- When Naomi Williams' first child, Julian, was
born in 1996, at first he seemed the picture of health. But as she and her
husband Dan fussed over their newborn in the recovery room, Julian began to
seem lethargic and threw up some clear liquid. His temperature dropped steadily
despite skin-to-skin contact and heated blankets.
Then -- less than six hours after he was born -- the Williamses
watched helplessly as Julian was whisked from his mother's arms into the
neonatal intensive care unit. Doctors at the San Francisco hospital feared a
blood-borne infectious condition called neonatal sepsis, which can swiftly
progress in infants to cause death.
The next time Naomi Williams saw her son, he lay in an
incubator under 24-hour observation, hooked to an intimidating array of
machines that provided, among other things, intravenous antibiotics.
You may never have heard of neonatal sepsis, a worldwide killer
that's comparatively uncommon in the U.S. because it's easily treated with
antibiotics. But every year, according to government estimates, 300,000
American newborns are rushed into intensive care, stuck with an IV, and placed
amid a tangle of monitors for anywhere from 24 hours to a week or more, because
doctors fear they have sepsis.
In fact, according to the same estimates, only one in 17
infants treated for sepsis actually has it. The problem: The best test
currently available is a blood culture that takes days to accurately diagnose
sepsis, while the infectious condition can kill an infant within hours. Doctors
can't afford to wait.
Now a new blood test being clinically evaluated could spare the
anguish for the vast majority of such families -- and at least some of the
estimated $800 million in annual treatment costs. The Williams family, fully
insured, racked up $15,000 in intensive-care charges for Julian. "What if
we hadn't had insurance, or had been underinsured?" wonders Naomi
The new test, originally developed by a team of researchers at
Stanford University and licensed to Massachusetts-based CompuCyte Corp., could
provide a definitive diagnosis of sepsis in less than 20 minutes. It works by
measuring inflammation in white blood cells. "There are very few conditions
in which an infant at birth, or shortly after birth, shows evidence of
overwhelming inflammation. The white blood cells are very sensitive to
infection, and the body's reaction is to turn those on as the first line of
defense to kill bacteria," says Timothy Holzer, PhD, CompuCyte's vice
president for biomedical development.
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