The FDA granted Breakthrough Device Designation to ScolimiR-3D, VB Spine’s blood test designed to assess the risk of disease progression in patients diagnosed with adolescent idiopathic scoliosis.
ScolimiR-3D uses a standard blood draw to measure six circulating microRNAs associated with adolescent idiopathic scoliosis progression and classify a patient’s risk of developing a severe spinal curve, according to a Sept. 29 news release.
In a Scientific Reports study of 116 patients with adolescent idiopathic scoliosis, the six-microRNA panel that forms the basis of the test predicted the risk of developing severe scoliosis with 100% sensitivity and 100% specificity in validation testing.
The designation is the first granted to a predictive diagnostic scoliosis risk assessment test, according to VB Spine. The company said the test is designed to provide physicians with information about progression risk that could inform treatment planning, including bracing.
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