Axial Biotech plans to launch next year the ScoliScore AIS Prognostic Test, a DNA-based test that gauges the likelihood of progression of adolescent idiopathic scoliosis.
Approximately 7 million people in the US have scoliosis, a condition that causes abnormal curvature of the spine. Standard monitoring methods involve analyzing the curvature of the spine through x-rays over a period of years. If the curve continues to progress, treatments include spinal bracing or spinal fusion surgery.
According to the company, ScoliScore will allow doctors to determine whether an observed spinal curvature will progress into a severe form of scoliosis in adolescents, and determine the appropriate treatment earlier.
The diagnostic was developed out of a genome-wide association study that identified a panel of 53 genetic markers associated with severe curve progression. Axial Biotech researchers collected DNA samples from over 9,500 patients at 85 clinical sites worldwide. The test was validated in two separate clinical trials, the company said.
Axial Biotech has inked an agreement with DePuy Spine to sell and market the test and plans to initially launch ScoliScore among a small group of physicians in the US. Patient samples will be analyzed at the company’s own CLIA-certified laboratory.
“Our long-term vision is to utilize the knowledge and capabilities gained from the development of this test and apply it to other spinal diseases,” John Climaco, CEO of Axial Biotech, said in a statement.