New test doubles the diagnostic accuracy for
necrotizing enterocolitis
NEW
ORLEANS, May 6, 2024 /PRNewswire/ -- Last
month a new utility patent, US Patent 11,953,501, was issued to LSU
Health New Orleans for a noninvasive test called NECDetect
that aids in early detection of necrotizing enterocolitis (NEC), a
potentially fatal condition in premature infants. The diagnostic
scoring system was invented by Sunyoung
Kim, PhD, professor of genetics at LSU Health New Orleans'
School of Medicine and is a continuation of US Patent 11,493,515.
NEC is the second deadliest disease in preemie babies and is the
most common, serious gastrointestinal disease affecting newborn
infants, according to the National Institute of Child Health and
Human Development. NEC requires a personalized method to diagnose
the condition as early as possible as it can cause parts of the
baby's intestine to become inflamed, die and can drive other
complications. Health care providers consider this disease as a
medical and surgical emergency of importance.
Currently X-rays are used to diagnose advanced NEC, but the test
sensitivity can be as low as 44%. However, the LSU Health New
Orleans research team showed that it was possible to double the
accuracy of diagnosis by using a noninvasive NECDetect biomarker
panel performed on stool samples which can identify 93% true
positives and 95% true negatives. NECDetect's development was
fast-tracked with a Breakthrough Device Designation by the Food and
Drug Administration.
In 2017, Kim founded Chosen Diagnostics Inc, a spinout
company, to develop and commercialize the technology. An Express
License for Faculty Startups agreement executed by LSU Health New
Orleans and Chosen Diagnostics Inc in 2020 grants the company the
exclusive license to this portfolio of patent and patent
applications. Chosen Diagnostics Inc has been awarded $4 million in Small Business Innovation Research
(SBIR) grants from the National Institutes of Health and the
National Science Foundation (NSF). The latest phase two SBIR grant
from NSF was just awarded last month.
"This second patent highlights that the inventions around rare
disease diagnosis can be expanded in a meaningful way. Identifying
babies who are at risk of NEC before intestinal inflammation is out
of control allows doctors and nurses in intensive care units to
take action to save a child's life," notes Kim. "Necrotizing
enterocolitis continues to be a devastating disease for preemie
babies who require long hospital stays. Methods in this patent to
score disease severity are attractive to diagnostic companies that
already provide equipment to hospital pathology labs and for drug
companies interested in tackling NEC therapies."
The National Institute of Child Health and Human Development
estimates that NEC affects about 9,000 of the 480,000 infants born
preterm each year in the United
States. The population most at risk for NEC is increasing
because the number of very low birth weight babies who survive
continues to grow due to technological advances in care. However,
the percentage of very low birth weight infants who develop NEC
remains steady, at about 10%. One-third of infants with NEC die
from the disease. Surgical survivors require lifelong care that
requires millions of dollars.
"When faculty actively consider societal needs in their
research, the resulting innovations and intellectual property are
more impactful and market-ready," says Marcus Brown, PhD, licensing associate at LSU
Health New Orleans' Office of Innovation & Partnerships. "Dr.
Kim, fellow co-inventors, and Chosen Diagnostics are prime examples
of how faculty-founded startups can successfully obtain funding for
commercialization of their innovative research."
In addition to this US patent, patent applications are pending
in Canada, Europe, Hong
Kong, Australia,
New Zealand and China.
To learn more about LSU Health New Orleans' commitment to
innovation, visit lsuhsc.edu.
About LSU Health New Orleans
LSU Health New Orleans
educates Louisiana's health care
professionals. The state's health sciences university leader, LSU
Health New Orleans includes a School of Medicine with campuses in
Baton Rouge and Lafayette, the state's only School of
Dentistry, Louisiana's only public
School of Public Health, and Schools of Allied Health Professions,
Nursing, and Graduate Studies. LSU Health New Orleans faculty take
care of patients in public and private hospitals and clinics
throughout the region. In the vanguard of biosciences research, the
LSU Health New Orleans research enterprise generates jobs and
enormous annual economic impact. LSU Health New Orleans faculty
have made lifesaving discoveries and continue to work to prevent,
advance treatment or cure disease.
Media Contact:
Alicia
Vial, APR
(504) 487-2230
alicia@gambelpr.com
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SOURCE LSU Health New Orleans