School of Medicine

The Pulse

Spin-Out Company Chosen Diagnostics Awarded SBIR Grant

Leslie Capo, Director of Information Services

The National Science Foundation has awarded Chosen Diagnostics, Inc., an LSU Health New Orleans spin-out company, a $224,758 Small Business Innovation Research Program (SBIR) Phase I grant. The funding will support further development of a new noninvasive and more accurate way to diagnose a fatal disease of premature babies developed by an LSU Health New Orleans basic science researcher and her team. Sunyoung Kim, Ph.D., Professor of Biochemistry and Molecular Biology at LSU Health New Orleans School of Medicine, invented a diagnostic biomarker test for necrotizing enterocolitis (NEC) and then started Chosen Diagnostics Inc to advance its development and commercialization and save lives of premature babies.

“Right here in New Orleans, we can create new diagnostic tests for deadly diseases,” says Dr. Kim, who is also CEO of Chosen Diagnostics. “Professors, doctors and nurses from different schools and departments at LSU Health worked together for three years to create this health care solution. Equally important, this health care innovation was created together with the parents, guardians, and caretakers of preterm infants in our communities. Nearly 70% of preemie babies in our communities are African American. It became critical that the health care solution for NEC was safe and tailor-made for the ethnic group that is most affected by this disease. This award allows the small business-university collaboration to build kit reference standards that accommodate human diversity. We will be working with proteomics core and other commercial entities to assist us in these efforts.”

The project will optimize the choice of reference standard and detection method for the NEC biomarker protein. Current clinical diagnostics rarely address a target protein with extensive variation that is age- and race-dependent. The goal of this project is to develop clinical reference standards for the detection of NEC that are equally robust across different ethnic groups in hospital pathology settings.

“The non-invasive format of our diagnostic test, necessary for fragile preemies, seamlessly integrates into existing pathology lab workflows, which will also reduce hospital stays and decrease health care costs,” adds Kim.

NEC has a mortality rate as high as 50%. Many babies do not live long after diagnosis, and those who survive can have lifelong neurological and nutritional complications. No clinical test had been established as the gold standard to diagnose NEC. X-rays are now used to diagnose advanced disease, but their sensitivity can be as low as 44%. Conversely, the Neonatal DDx biomarker panel developed by Kim in her lab at LSU Health New Orleans, is performed on stool samples and identifies 93% true positives and 95% true negatives in diagnosing the disease.

According to the National Science Foundation, the SBIR program is intended to support scientific excellence and technological innovation through the investment of federal research funds to build a strong national economy by stimulating technological innovation in the private sector; strengthening the role of small business in meeting federal research and development needs; increasing the commercial application of federally supported research results; and fostering and encouraging participation by socially and economically disadvantaged and women-owned small businesses.

The technology will serve as a clinically deployable diagnostic for hospitals, reference labs, and drug companies, particularly high-acuity neonatal intensive care units.

Rebecca Buckley, Ph.D., Postdoctoral Research Associate in the Department of Biochemistry and Molecular Biology at LSU Health New Orleans School of Medicine, and Chosen Diagnostics Chief Operating Officer, will lead continuing research at LSU Health New Orleans.

“Our research objectives include identifying optimal reference standard composition for two common methods to quantify biomolecules in clinical settings and understanding usage limitations of these reference standards in the background of high sequence variation in the human population,” says Dr. Buckley.

The Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health awarded Chosen Diagnostics Inc, a $299,641 Phase I Small Business Technology Transfer award last year.

“This is the second grant award we have received in eight months,” notes Kim. “Having support from two federal science agencies concurrently is an important milestone for all of us,” concludes Kim. “It speaks to the utility and importance of our vision to create a novel diagnostic test that has long been sought.”