The assay will first be provided to a specific group of physicians and commercialized in the U.S. in 2009.
Axial Biotech has launched its molecular diagnostic that indicates the likelihood of progression to a severe curve for children with adolescent idiopathic scoliosis (AIS). The test will be marketed under the name ScoliScore™ AIS Prognostic Test.
The initial launch of the ScoliScore will be to a small group of physicians in the U.S. The test will be processed solely at Axial’s CLIA-certified laboratory. It will be made commercially available to physicians nationwide in 2009. Axial Biotech has signed an agreement with DePuy Spine to sell and market ScoliScore.
ScoliScore was developed through a genome wide association study that identified 53 genetic markers associated with severe curve progression. This research collected DNA samples from over 9,500 patients from 85 clinical sites across world. The test was then further validated in two separate clinical trials, Axial Biotech points out.
“For decades, spine surgeons have been looking for ways to determine which patients may progress and which may not,” comments Ken Ward, M.D., CSO for Axial Biotech. “Currently, most patients diagnosed with scoliosis have spinal x-rays repeated over several years because of the lack of precise clinical indicators or markers that can identify the likelihood of severe curve progression. This lack of predictive information is very inefficient and can cause adolescents to be given years of unnecessary radiation exposure.”