Terran Biosciences announces that it has obtained U.S. FDA clearance for NM-101, a cloud-based software tailored for analyzing neuromelanin-sensitive MRI scans. This marks it as the first FDA-cleared solution of its kind, with integration into hospital workflows. Doctors can efficiently send MRI images via the hospital’s system, receiving a timely report that aids in neuromelanin-related diagnosis.

“This is a big moment for us and our collaborators and we’re thrilled to bring this new tool to doctors where it can begin benefiting patients,” says Terran Biosciences Founder and CEO Sam Clark, MD, PhD. “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.”

Neuromelanin is a molecule associated with certain cell populations in the brain. While neuromelanin was first described in the 19th century, researchers have elucidated its possible role as a biomarker for neurological disorders such as Parkinson’s disease in the last two decades. Studies show that neuromelanin MRI may provide useful adjunctive information to aid in the evaluation of Parkinson’s disease and avoids the disadvantages of current adjunctive imaging modalities such as DaT-SPECT, which requires a five-hour procedure, intravenous radiation exposure, and can cost well over $3,000.

A recent meta-analysis of 12 clinical neuromelanin MRI studies comprising 403 patients with Parkinson’s disease and 298 control participants concluded that neuromelanin MRI provided a “favorable diagnostic performance in discriminating patients with Parkinson’s disease from healthy controls.” The benefits of neuromelanin MRI include:

  • Fast scan time (less than 10 min of additional time in the scanner).
  • No injections.
  • No exposure to radiation.
  • Cost-effectiveness. It can be added to the MRI that most patients already receive as part of their initial workup.
  • Potential to provide adjunctive information in indications beyond Parkinson’s disease, such as Alzheimer’s disease and schizophrenia. 

David Sulzer, PhD, professor of neurobiology at Columbia University Vagelos College of Physicians and Surgeons and co-author of multiple studies using neuromelanin MRI, comments, “The research suggests that neuromelanin MRI is a promising approach with the potential to become part of the standard of care for the workup of all patients suspected of Parkinson’s and related diseases.”

One of the first researchers to study neuromelanin, Luigi Zecca, MD, PhD, head of the Brain Aging and Neurodegeneration Unit at the Institute of Biomedical Technologies-CNR in Milan, commented on the news, stating: “After many years of hard work to show neuromelanin MRI could be a powerful tool, it’s exciting to see this technology finally become available to physicians and patients.”

Despite these benefits, there have been no FDA-approved devices capable of providing clinicians with analysis of neuromelanin MRI due to a lack of automation and standardization that has prevented its clinical use. Historically, the standardization of neuromelanin measurement has been difficult due to variability in results among MRI scanners, even those from the same manufacturer and model. NM-101 contains algorithms that enabled for the first time the fully automated analysis and the cross-scanner harmonization of neuromelanin MRI scans.

Guillermo Horga, MD, PhD, associate professor of psychiatry at Columbia University Vagelos College of Physicians and Surgeons, and Clifford Cassidy, PhD, now assistant professor of cellular and molecular medicine at the University of Ottawa, were pioneers of the original algorithms and authors of studies using neuromelanin MRI in neuropsychiatric disorders including schizophrenia.

“It’s great to see neuromelanin MRI become more accessible in clinical settings,” says Horga. “We hope this opens the door for the adoption of neuromelanin MRI into the clinical workflow for patients with neuropsychiatric disorders.”