U.S. Patent 11,493,515 was issued to LSU Health New Orleans for a noninvasive test that more accurately diagnoses a potentially fatal condition in premature infants.
Sunyoung Kim, PhD, professor of Biochemistry and Molecular Biology at LSU Health New Orleans Schools of Medicine and Graduate Studies, led a research team that invented a diagnostic biomarker test for necrotizing enterocolitis (NEC) called NECDetect.
According to the National Institute of Child Health and Human Development, NEC is the most common, serious gastrointestinal disease affecting newborn infants. The tissue lining the intestine becomes inflamed, dies, and can slough off. Healthcare providers consider this disease as a medical and surgical emergency. X-rays are now used to diagnose advanced disease, but their sensitivity can be as low as 44%. Conversely, the noninvasive NECDetect biomarker panel performed on stool samples identifies 93% true positives and 95% true negatives in diagnosing the disease.
In 2017, Kim founded Chosen Diagnostics Inc, a spinout company, to develop and commercialize the technology. An Express License for Faculty Startups (ELFS) agreement executed by LSU Health and Chosen Diagnostics Inc in 2020 grants the company the exclusive license to this portfolio of patent and patent applications.
“This patent is an important milestone in protecting the commercial potential of molecular diagnostic tools in intensive care units,” says Kim. “Necrotizing enterocolitis continues to be a devastating disease for preemie babies who require long hospital stays. This utility patent is attractive to diagnostic companies that already provide equipment to hospital pathology labs and for drug companies interested in tackling gut disease therapies.”
Understanding Necrotizing Enterocolitis
The National Institute of Child Health and Human Development estimates that necrotizing enterocolitis 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. The percentage of very low birth weight infants who develop NEC remains steady, however, at about 7%. NEC continues to be one of the leading causes of illness and death among preterm infants, although it can also affect full-term babies, usually those with another serious illness or risk factor. Roughly 15-40% of infants with NEC die from the disease. Surgical survivors require lifelong care.
Rebecca Buckley, PhD, LSU Health New Orleans Research Assistant Professor of Biochemistry (and former postdoctoral research associate), is a co-inventor and Chosen Diagnostics’ chief operating officer. LSU Health inventors also included Duna Penn, MD a member of the Neonatology faculty at the time, and Zeromeh Gerber MD, a former LSU Health neonatology fellow, along with Carl Sabottke, a medical student at the time of the initial application.
“This patent is a rarity in that the majority of the team are women,” says Kim. “In the 2020 United States Patent and Trademark Office database of all patents issued, only four women in Orleans Parish are inventor-patentees for the whole year. This number has not changed much since 1976.”
Chosen Diagnostics Inc has been awarded $3 million in SBIR and STTR grants, and NECDetect’s development was fast-tracked with a Breakthrough Device Designation by the Food and Drug Administration (FDA).
“Intellectual property is the foundation upon which successful biotech businesses are built,” says Patrick Reed, RTTP, LSU Health New Orleans Assistant Vice Chancellor, Innovation & Partnerships. “Working with external counsel, the inventors, and Chosen Diagnostics, we have ensured that this important work is adequately protected, enabling Chosen to attract investment for further R&D and commercialization.”
In addition to this U.S. patent, patent applications are pending in Canada, Europe, Hong Kong, Australia, New Zealand, and China.