Chosen Diagnostics’ NECDetect for Preterm Babies Authorized as Breakthrough Device by FDA
NEW ORLEANS, LA. (Nov. 16, 2020) — Chosen Diagnostics is pleased to announce that the US Food & Drug Administration (FDA) has granted its NECDetect, and its proposed indication for use, the designation of a ‘Breakthrough Device.’ A spinout of LSU Health, Chosen Diagnostics works to develop innovative diagnostic platforms for gastrointestinal inflammatory diseases in babies and children. Through noninvasive measures, NECDetect will be used to identify necrotizing enterocolitis (NEC), a gastrointestinal disease primarily seen in preterm infants.
Necrotizing enterocolitis is the most common gut inflammatory disease in preterm babies, impacting 6,000 infants a year in the United States alone, with a fatality rate of up to 50 percent. NEC occurs when tissues in the large intestine are damaged or die as a result of inflammation. Bacteria from the intestinal tract can then leak into the abdomen causing serious infections and/or death. Chosen Diagnostics’ hope is that by improving the diagnosis of the disease, it will assist in a decreased mortality rate of those infants impacted and allow for a reduction in the life-long health complications for those who survive.
“We are delighted to receive the Breakthrough Device Designation, as it is clear validation of the work we are doing at Chosen Diagnostics,” said Sunyoung Kim, Ph.D., chief executive officer of the company. “This FDA decision supports us creating healthcare solutions for neonatal and pediatric medical problems, and is a catalyst for improving clinical outcomes for the most fragile patient population. We look forward to working collaboratively with the FDA to advance our novel diagnostic assay,” said Rebecca Buckley, Ph.D., the company’s chief operating officer.
The FDA’s Breakthrough Devices Program is reserved for certain medical devices that provide for more effective diagnosis of life-threatening or irreversibly debilitating diseases or conditions, such as NEC. Medical devices granted the designation are technological breakthroughs and/or offer significant improvement compared to current alternatives. Intended to get these innovative medical devices to market faster, the Breakthrough Devices Program expedites their development, assessment and review.
Chosen Diagnostics’ submission to the FDA focused on two features of NECDetect that distinguish the diagnostic test from the current standard of care and meet the criteria for the Breakthrough Device Designation: unequivocal, as well as early, identification of NEC. For more information on Chosen Diagnostics, please visit, www.ChosenDiagnostics.com.