This builds on the company’s 2019 Phase 1 award, and funding will support completing the prototype of NECDetect, testing for regulatory approval for clinical diagnostic use, and a scaling up a larger confirmational study of NECDetect for necrotizing enterocolitis.
Founded in 2017, the company, which is owned by women and grew out of research at LSU, 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.
