NEW ORLEANS – Last month, the United States Patent and Trademark Office issued a new utility patent to LSU Health New Orleans for a noninvasive test called NECDetect that aids in early detection of necrotizing enterocolitis, a potentially fatal condition in premature infants. The diagnostic scoring system was invented by Sunyoung Kim, professor of genetics at the LSU Health New Orleans School of Medicine.
“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,” said a spokesperson for LSU Health New Orleans. “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%, said the spokesperson. LSU Health New Orleans said its 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, 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 has been awarded $4 million in Small Business Innovation Research grants from the National Institutes of Health and the National Science Foundation. 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,” said 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.”
“When faculty actively consider societal needs in their research, the resulting innovations and intellectual property are more impactful and market-ready,” says Marcus Brown, licensing associate at LSU Health New Orleans’ Office of Innovation and 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.
