Terran Biosciences is the first company ever to gain FDA clearance for a software to analyze neuromelanin MR scans to evaluate neurological conditions.

Terran Biosciences first to gain FDA clearance for AI-based neuromelanin MR assessment software

January 16, 2024
by John R. Fischer, Senior Reporter
NM-101, a cloud-based solution designed by biotech company Terran Biosciences to analyze neuromelanin-sensitive MR scans has scored FDA clearance, making it the first assessment software in the world for such exams and potentially paving the way for shorter and less expensive imaging procedures that reduce patient radiation exposure.

Neuromelanin is a molecule associated with certain types of brain cells and has long been suggested to be a potential biomarker for neurological disorders, such as Parkinson’s disease. But standardizing neuromelanin measurements has been challenging due to variations in results among different MR scanners, including those with the same make and model.

NM-101 leverages algorithms that fully automate analyses and cross-harmonize these scans for the first time ever. The solution integrates into existing hospital and imaging center workflows, transferring neuromelanin MR images to Terran directly through the PACS system, with a full report sent back in under an hour. It also can show, when interpreted by a neuroradiologist, if neuromelanin is an adjunct to diagnosis for Parkinson’s and other diseases, including Alzheimer’s and schizophrenia.

According to Terran, by making neuromelanin MR imaging easier to interpret, the software will save patients time and money by allowing them to avoid current adjunctive imaging such as DaT-SPECT, a five-hour procedure that exposes them to intravenous radiation and can cost well over $3,000. In contrast, neuromelanin MR scans can be performed in less than ten minutes; can be added to patient exams as part of initial workups, reducing costs; and include no injections or radiation exposure.

“We were excited to partner with leading researchers in the field and conduct the key development steps necessary to bring it through to FDA clearance. We believe this technology could become very important in the clinical workflow of patients with neurological and psychiatric disorders,” said Terran Biosciences Founder and CEO Dr. Sam Clark in a statement.

Prior studies support the fact that neuromelanin MR exams provide adjunctive information for the evaluation of Parkinson’s disease. A recent meta-analysis of 12 clinical neuromelanin MR studies, published in European Radiology, comprised 403 patients with Parkinson’s and 298 healthy ones, and found that the scans provided a “favorable diagnostic performance in discriminating patients with Parkinson’s disease from healthy controls.”

Dr. Clifford Cassidy, assistant professor of cellular and molecular medicine at the University of Ottawa, was one of the original developers of the algorithms used by NM-101 and authored studies on the use of these exams for assessing neuropsychiatric disorders including schizophrenia. He says that the approval of this solution opens up the opportunity to better analyze multiple conditions.

“It allows us to obtain potentially useful adjunctive information about many other diseases such as Alzheimer’s disease, and PTSD,” he said.