VB Spine’s blood test for predicting scoliosis progression has received Breakthrough Device Designation from the US Food and Drug Administration.

The test, called ScolimiR-3D, measures circulating microRNAs in the blood to predict how adolescent idiopathic scoliosis will develop. It aims to replace repeated spinal X-rays in teenagers.

In a validation study of 116 adolescent patients, published in the journal Scientific Reports, the test showed 100 percent sensitivity and 100 percent specificity in predicting curve progression.

The science comes from Professor Alain Moreau of the CHU Sainte-Justine research centre and Universite de Montreal, with exclusive worldwide rights held by VB Spine.

Co-CEO Marc Viscogliosi said the designation reflects the test’s potential to change scoliosis care. The FDA designation gives promising devices priority review, faster feedback and senior-level support. VB Spine plans to move toward regulatory clearance and wider clinical use.

The company says a simple blood draw could replace years of repeated X-rays for growing children. Clinicians welcomed the breakthrough as a step toward gentler, more precise care for scoliosis patients.