Patent Issued to LSU Health New Orleans Expands Family of Technologies for Diagnosis of Life-Threatening Preemie Condition
New test can increase accurate diagnosis of the nation’s second deadliest preemie disease 50%
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 (pictured, right), 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 premature 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 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.