Test for Early Diagnosis of Life-Threatening Preemie Disease Advances

Prestigious NSF I-Corps Award to LSU Health New Orleans team to help move promising technology to marketplace

The National Science Foundation (NSF) has chosen an LSU Health New Orleans team that developed a test for the early detection of a potentially life-threatening gastrointestinal disease affecting pre-term, low birthweight babies to receive expert guidance to move the technology forward. NSF awarded LSU Health New Orleans a $50,000 grant so the LSU Health New Orleans researchers led by Sunyoung Kim, PhD, Associate Professor of Biochemistry and Molecular Biology at LSU Health New Orleans School of Medicine, can participate in the national NSF Innovation Corps (I-Corps) Program in January 2017.

Kim developed a novel diagnostic biomarker panel for necrotizing enterocolitis, a potentially fatal condition described as the most common and serious intestinal disease affecting pre-term infants. The disease develops when tissue in the small or large intestine is injured and begins to die. Inflammation follows, and sometimes the intestine perforates, leaking bacteria and waste. The resulting infection can quickly overwhelm these fragile babies.

“Neonatologists at LSU Health approached my research group to develop a better diagnostic test for necrotizing enterocolitis two years ago,” notes Kim. “The disease affects one out of eight infants who are extremely premature; it also has a high rate of mortality. Furthermore, there is a 3- to 4-fold greater risk for male, African American infants to develop necrotizing enterocolitis. Louisiana has one of the highest rates of preterm births in the United States and has a large African American population. Developing health care solutions for the people of the state is our responsibility, our calling and our strength.”

Diagnostic tests are critical for disease management and better outcomes, but current ones have poor success in identifying necrotizing enterocolitis. The current gold standard diagnostic method is X-ray, which has a true positive rate of only 44%. LSU Health New Orleans’ noninvasive Neonatal DDx biomarker panel, which is performed on stool samples, identifies 93% true positives and 95% true negatives in diagnosing the disease that affects about 6,000 premature infants every year in the US.

To make the test widely available, Kim started a spin-out company, Chosen Diagnostics, to commercialize this promising new technology. Because NSF “recognizes that transitioning technology out of an academic laboratory requires a skill set and knowledge base that differ from those required for research and those skills and expertise are much more common in a start-up environment than an academic one,” NSF established the I-Corps Program. According to NSF, the I-Corps program “teaches NSF grantees to identify valuable product opportunities that can emerge from academic research and offers entrepreneurship training to participants by combining experience and guidance from established entrepreneurs through a targeted curriculum.”

I-Corps teams are composed of the principal investigator(s) (PI), an entrepreneurial lead (EL), and a mentor, typically an experienced or emerging entrepreneur with experience in transiting technology out of academic labs.

Kim, who also has experience in grant management and intellectual property development, is the principal investigator. Rebecca Buckley, PhD, a postdoctoral researcher working in Kim’s lab at LSU Health New Orleans who has relevant experience and deep knowledge of all technical aspects of the biomarker panel, is the entrepreneurial lead. James Davis, PhD, Director of the Stephenson Entrepreneurship Center in LSU's E. J. Ourso College of Business and an entrepreneur with a proven background in creating new business opportunities through technology, is the I-Corps team mentor. The team participated in a regional I-Corps Program at LSU A & M in Baton Rouge over the summer. With the new award, the team will continue its education and training in California in the new year.

Invited I-Corps participants learn through a special, accelerated version of Stanford University's Lean LaunchPad course. The course teaches academics how to talk to potential customers, partners and competitors, and encounter and manage the challenges and uncertainty of successfully translating their discoveries to the market.

“In academia, we work toward having strong links to outreach,” says Kim. “However, this effort is purposeful in establishing direct links with the public stakeholders, patients and physicians. We are not so far removed from providing solutions to real world problems, and the I-Corps Program provides the means to think critically about how to do so. There is an immense power in listening to people who want solutions from science and who directly benefit from our expertise.”

The NSF says the I-Corps environment is fast-paced and rigorous; teams are pushed, challenged, and questioned in the hope that they will learn quickly whether their ideas are worth pursuing. Teams are expected to complete at least ten customer interviews a week, which means that over the ten-week course, teams have contact with 100 potential customers.

“NSF’s I-Corps Program is invaluable in teaching scientists with great research the importance of knowing one’s customer,” notes Patrick Reed, Director of Technology Management at LSU Health New Orleans. “A great idea without a market is only a great idea; a great idea with a well-defined market and customer base will lead to public benefit – a core component of our mission.”

Biosciences research has other benefits in addition to solving health problems. “Academic inventions can be used to start spin-off companies that benefit the local New Orleans economy,” says Kim. “Our hope is that collaborations between science and medicine at LSU Health New Orleans will foster economic growth, resilience, and diversity for our city and our state. Toward these goals, we have benefitted tremendously from the technology management offices at LSU Health New Orleans and LSU Baton Rouge, as well as from the New Orleans Bioinnovation Center.”

Kim’s hopes for the technology and her startup revolve around the tiny beneficiaries of her labors. “By personalizing medical management of infants, our technology may prevent 1,000 infants from dying each year. The added benefit is it may also save US insurance companies $720 million in health care costs.”