The US Food and Drug Administration (FDA) has cleared NM-101 (Terran Biosciences), a cloud-based software platform to analyze neuromelanin-sensitive MRI scans, which could aid in the diagnosis of neurodegenerative diseases.
Research has suggested that neuromelanin is a potential biomarker for neurologic disorders such as Parkinson’s disease (PD).
A recent meta-analysis of 12 neuromelanin MRI studies with 403 patients with PD and 298 control participants found that neuromelanin MRI had “favorable” diagnostic performance in discriminating PD patients from healthy controls.
Until now, there were no FDA-approved devices capable of providing clinicians with analysis of neuromelanin MRI due to a lack of automation and standardization. NM-101 contains algorithms that enable fully automated analysis and the cross-scanner harmonization of neuromelanin MRI scans, the company explains in a news release.
NM-101 is designed to “seamlessly” integrate into existing workflows at hospitals and imaging centers, the company says.
The platform allows clinicians to send neuromelanin MRI images to Terran directly through the hospital picture archiving and communication system and receive results in less than 1 hour.
When interpreted by a neuroradiologist, NM-101 could provide information that may be helpful in determining neuromelanin association as an adjunct to diagnosis.
“We believe this technology could become very important in the clinical workflow of patients with neurological and psychiatric disorders,” Terran Biosciences Founder and CEO Sam Clark, MD, PhD, said in the release.
Neuromelanin MRI has the potential to become “part of the standard of care for the workup of all patients suspected of Parkinson’s and related diseases,” David Sulzer, PhD, professor of neurobiology at Columbia University Vagelos College of Physicians and Surgeons, New York, and co-author of multiple studies using neuromelanin MRI, commented in the news release.
“It’s great to see neuromelanin MRI become more accessible in clinical settings. We hope this opens the door for the adoption of neuromelanin MRI into the clinical workflow for patients with neuropsychiatric disorders,” added Guillermo Horga, MD, PhD, associate professor of psychiatry at Columbia University Vagelos College of Physicians and Surgeons.
Terran Biosciences has an exclusive license to the CNS biomarker software platform and related patents co-owned by Columbia University and Research Foundation for Mental Hygiene. Horga will receive a portion of the royalties paid to Columbia University for sales of the product.
Leave a Reply