ScolimiR-3D : From Quebec RNA research to FDA Breakthrough Device Designation

Press release published by VB Spine September 29, 2026 : https://www.vbspineco.com/fda-breakthrough-device-designation/

ARN Québec is proud to highlight an important milestone achieved by Dr. Alain Moreau, Professor at Université de Montréal, researcher at the CHU Sainte-Justine Azrieli Research Centre, and member of the Board of Directors of ARN Québec.

ScolimiR-3D, a blood test based on a six-circulating-microRNA signature discovered and developed through Dr. Moreau’s research program on adolescent idiopathic scoliosis, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).

This recognition represents an important example of how RNA-based discoveries originating from Québec academic research can be translated toward clinical applications and precision medicine.

And the story does not end with scoliosis. Dr. Moreau and his team have also developed promising microRNA-based diagnostic, prognostic and patient-stratification approaches for myalgic encephalomyelitis (ME), fibromyalgia (FM) and Long COVID.

The scientific discoveries are advancing. The next critical step is translation.

ARN Québec sees an exciting opportunity to connect these innovations with the right industrial partners and help transform promising microRNA signatures into clinically accessible tests for diseases where objective diagnostic and prognostic tools remain urgently needed. ScolimiR-3D demonstrates what can happen when RNA innovation, clinical research and industrial partnership converge. The ambition now is to build on this success and accelerate the translation of the next generation of RNA-based diagnostics.