Blog Post

Congratulations to Université de Montréal RNA biologist Dr. Alain Moreau on a major translational research milestone. The FDA has granted Breakthrough Device Designation to ScolimiR-3D, a novel microRNA-based blood test developed from research led by Dr. Moreau and colleagues at the Viscogliosi Laboratory in Molecular Genetics of Musculoskeletal Diseases. The assay measures a panel of six circulating microRNAs associated with progression of adolescent idiopathic scoliosis (AIS) and is designed to identify patients at risk of developing severe spinal curvature before significant progression occurs.

“For decades, physicians have had limited tools to determine which patients with adolescent idiopathic scoliosis are most likely to experience disease progression,” said Dr. Moreau. “The challenge in scoliosis is not simply detecting the curve—it is knowing where that curve is going. ScolimiR-3D was developed to bring that predictive dimension into clinical care: using a simple blood test to identify progression risk earlier, when there is still an opportunity to personalize treatment and potentially change a patient’s trajectory.”

This recognition highlights the real-world clinical impact of microRNA biomarker discovery and validation. Dr. Moreau’s work demonstrates how insights into non-coding RNA biology can be translated into innovative diagnostic tools that support precision medicine and improve patient care. With ScolimiR-3D becoming the first predictive scoliosis risk assessment test to receive FDA Breakthrough Device Designation, this achievement represents an exciting example of RNA science moving from the laboratory to the clinic and underscores the growing role of circulating microRNAs in disease prognosis and personalized treatment strategies.