New technology to diagnose fatal disease in preemies granted FDA's Breakthrough Device Designation

Reviewed by Emily Henderson, B.Sc.Nov 16 2020

A technology to diagnose a potentially fatal disease in premature infants invented by Sunyoung Kim, PhD, Professor of Biochemistry & Molecular Biology at LSU Health New Orleans School of Medicine, has been granted a Breakthrough Device Designation by the Food and Drug Administration (FDA). The noninvasive diagnostic biomarker, NECDetect, more accurately diagnoses necrotizing enterocolitis (NEC).

According to the FDA, the Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency's mission to protect and promote public health. The requirements for designation include at least one of the following: Represents Breakthrough Technology; No Approved or Cleared Alternatives Exist; Offers Significant Advantages over Existing Approved or Cleared Alternatives; Device Availability is in the Best Interest of Patients.

This FDA authorization is a milestone for us, as we aspire to change medical outcomes for GI disease in preemie babies. The fast-paced and thoughtful interactions with the FDA is another confirmation that our biomarker does fulfill a compelling, unmet need and can effectively diagnose NEC in a new and better way."

Dr. Sunyoung Kim, Ph.D., Professor of Biochemistry & Molecular Biology at LSU Health New Orleans School of Medicine

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, NECDetect 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.

Kim started the spinout company, Chosen Diagnostics Inc, to advance its development and commercialization. The next step is to work collaboratively with the FDA to help prioritize development and access for preemie patients in the neonatal intensive care unit.

"This is an exciting time in healthcare with the FDA working closely with companies designated as having disruptive technology and to help improve access to patients and their families," Kim adds.