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

LSU Health New Orleans receives patent for non-invasive test to diagnose fatal conditions 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 intestines 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 non-invasive 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 by LSU Health and Chosen Diagnostics Inc in 2020 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 diagnostics companies that already supply equipment to hospital pathology laboratories and to pharmaceutical companies interested in targeting therapies for 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 about 9,000 of the 480,000 premature babies 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 illness and death in premature babies, although 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. Surviving surgery requires lifelong care.

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Rebecca Buckley, PhD, LSU Health New Orleans Research Assistant Professor of Biochemistry (and former postdoctoral fellow), is co-inventor and chief operating officer of Chosen Diagnostics. The inventors of LSU Health also included two other women – Drs. Duna Penn, a neonatology faculty member at the time, and Zeromeh Gerber MD, a former neonatology fellow at LSU Health, along with Carl Sabottke, a medical student at the time, initiated the 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 United States Patent and Trademark Office's 2020 database of all issued patents, only four women in Orleans Parish are inventor patents year-round. This number has not changed significantly since 1976."

Chosen Diagnostics Inc. was awarded $3 million in SBIR and STTR grants, and development of NECDetect was accelerated with a Breakthrough Device Designation from the Food and Drug Administration (FDA).

“Intellectual property is the foundation upon which successful biotech companies are built,” says Patrick Reed, RTTP, LSU Health New Orleans Associate Vice Chancellor, Innovation & Partnerships. “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 R&D and commercialization.”

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

Source:

Louisiana State University Center for Health Sciences

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