Chosen Diagnostics Awarded $2.1 Million to Advance Test to Better Diagnose Necrotizing Enterocolitis
Leslie Capo, Director of Information Services
Chosen Diagnostics Inc, a woman-owned spinout company based on an LSU Health New Orleans
research breakthrough, has been awarded a $2.1M Phase 2 Small Business Innovation
Research (SBIR) grant by the National Institutes of Health. The non-dilutive NIH award
will advance the development and commercialization of a noninvasive diagnostic biomarker
test for necrotizing enterocolitis called NECDetect invented by Sunyoung Kim, Ph.D.,
Professor of Biochemistry and Molecular Biology at LSU Health New Orleans School of
Medicine. The principal investigator for the grant is Rebecca Buckley, Ph.D., a postdoctoral
research associate in the Department of Biochemistry and Molecular Biology at LSU
Health New Orleans School of Medicine.
The SBIR grant will build upon a Phase 1 Small Business Technology Transfer (STTR) award to Chosen Diagnostics Inc by the National Institutes of Health in 2019. The current funding will support the completion of the prototype build for NECDetect, testing for regulatory approval for clinical diagnostic use, and a larger-scale study to confirm that NECDetect can be used to predict the disease before its advancement to severe forms of necrotizing enterocolitis.
Progress has been steady since Chosen Diagnostics Inc was founded in 2017. The company has completed the first clinical study to demonstrate proof of concept, obtained confirmation that NECDetect will be a best-in-class product that will save infant lives through its FDA Breakthrough Device designation in 2020, and begun developing the NECDetect prototype for clinical use.
Necrotizing enterocolitis (NEC) is the most common serious gastrointestinal disease affecting newborns, primarily premature infants. More premature infants are surviving thanks to advancements in neonatal care, but the risk of NEC has also grown. NEC has a mortality rate as high as 50%. The disease is characterized by inflammation that kills intestinal tissue. Many babies do not live long after diagnosis, and those who survive can have lifelong neurological and nutritional complications. 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.
“We are humbled to receive support and encouragement from the National Institute of Child Health and Human Development to commercialize NECDetect,” says Dr. Buckley, who also serves as Chief Operating Officer of Chosen Diagnostics Inc.
According to the U.S. Small Business Association, the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs are highly competitive programs that encourage domestic small businesses to engage in Federal Research/Research and Development (R/R&D) with the potential for commercialization. Through a competitive awards-based program, SBIR and STTR enable small businesses to explore their technological potential and provide the incentive to profit from its commercialization. By including qualified small businesses in the nation's R&D arena, high-tech innovation is stimulated, and the United States gains entrepreneurial spirit as it meets its specific research and development needs.
“It is an important validation for the spinout company,” notes Dr. Kim who is also
Chosen Diagnostics' Chief Executive Officer and the grant's co-principal investigator.
“We're grateful that we are positioned to be stronger post-COVID than when we entered
the pandemic.”