LSU Health New Orleans receives patent for non-invasive test to diagnose fatal diseases in premature babies

LSU Health New Orleans receives patent for non-invasive test to diagnose fatal diseases in premature babies

U.S. Patent 11,493,515 is issued to LSU Health New Orleans on November 8, 2022 for a non-invasive test that more accurately diagnoses a potentially fatal condition in premature babies. Sunyoung Kim, PhD, professor of biochemistry and molecular biology at the 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 and serious gastrointestinal disease in newborns. The tissue lining the intestine becomes inflamed, dies, and may slough off. Healthcare providers consider this illness a medical and surgical emergency. X-rays are now used to diagnose advanced diseases, 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, Dr. Kim Chosen Diagnostics Inc, a spinout company, to develop and commercialize the technology. An Express License for Faculty Startups (ELFS) agreement signed in 2020 by LSU Health and Chosen Diagnostics Inc. grants the company exclusive license to this portfolio of patents and patent applications.

This patent is an important milestone in protecting the commercial potential of molecular diagnostic tools in intensive care units. Necrotizing enterocolitis remains a devastating disease for premature infants, requiring long hospital stays. This utility model is attractive to diagnostic companies that already supply equipment to hospital pathology laboratories, as well as pharmaceutical companies interested in treating intestinal diseases.”

Dr. Sunyoung Kim, PhD, professor of biochemistry and molecular biology at the LSU Health New Orleans Schools of Medicine and Graduate Studies

The National Institute of Child Health and Human Development estimates that NEC affects approximately 9,000 of the 480,000 premature infants born each year in the United States. The population most at risk for NEC is increasing as the number of surviving very low birth weight babies continues to increase due to technological advances in care. However, the percentage of very low birth weight infants who develop NEC remains constant at approximately 7%. NEC remains a leading cause of morbidity and death in premature babies, but it can also affect full-term babies, usually those with another serious illness or risk factor. Fifteen to forty percent of infants with NEC die from the disease. Surgical survivors require lifelong care.

Rebecca Buckley, PhD, research assistant professor of biochemistry at LSU Health New Orleans (and former postdoctoral fellow), is co-inventor and chief operating officer of Chosen Diagnostics. LSU Health's creators also included two other women - Drs. Duna Penn, then a neonatology faculty member, and Zeromeh Gerber MD, a former LSU Health neonatology fellow, as well as Carl Sabottke, then a medical student initiative application.

“This patent is a rarity in that the majority of the team is made up of women,” adds Dr. Kim added. "In the U.S. Patent and Trademark Office's 2020 database of all issued patents, only four women in Orleans Parish are inventor patents throughout the year. This number has not changed significantly since 1976."

Chosen Diagnostics Inc. has received $3 million in SBIR and STTR grants, and the development of NECDetect was accelerated by its Breakthrough Device designation from the Food and Drug Administration (FDA).

“Intellectual property is the foundation for building successful biotech companies,” says Patrick Reed, RTTP, associate vice chancellor for innovation and partnerships at LSU Health New Orleans. “By working with external consultants, the inventors and Chosen Diagnostics, we have ensured that this important work is appropriately protected so that Chosen can attract investment for further research and development and commercialization.”

In addition to this US patent, patent applications are pending in Canada, Europe, Hong Kong, Australia, New Zealand and China.

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