According to the company, this new molecular diagnostic tool marks a major advancement in which medical treatments can be personalized to patients diagnosed with this deforming disease. The test will be marketed under the name of ScoliScore adolescent idiopathic scoliosis (AIS) prognostic test.
The initial launch of the ScoliScore test will be to a small group of physicians in the US. The test will be processed solely at Axial’s CLIA certified laboratory, which meets all applicable state and federal guidelines. 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 by utilizing a genome wide association study that identified a panel of 53 genetic markers associated with severe curve progression. This scoliosis research involved collecting DNA samples from over 9,500 patients from 85 clinical sites throughout the world. The test was then further validated in two separate clinical trials.
John Climaco, CEO and president of Axial Biotech, said: The launch of ScoliScore illustrates the company’s commitment to making critical information from molecular diagnostic tests more broadly available to spinal surgeons, patients, and their family members. 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.