Axial Biotech, Inc., a company personalizing spine care through the development of molecular diagnostics, announced today that its SCOLISCORE(TM) AIS Prognostic Test is now being made available to spine specialists in the United States. SCOLISCORE is a saliva-based genetic test designed to predict the risk of progression of scoliosis, an abnormal lateral curvature of the spine. Spine surgeons from 40 medical centers throughout the U.S. were introduced to the test and have been defining its clinical use since December 2008. DePuy Spine, Inc. will market the test for Axial and will feature SCOLISCORE at the Scoliosis Research Society (SRS) Annual Meeting taking place this week.
One hundred thousand children are diagnosed with scoliosis every year in the U.S. and must be followed on a consistent, often quarterly basis, to determine and assess disease progression. The SCOLISCORE Test is designed for male and female patients diagnosed with Mild (10-25 degree Cobb Angle) Adolescent Idiopathic Scoliosis (AIS) who are from 9 through 13 years of age, and who are self-reported as Caucasian (North American, South American, European, Eastern European, Middle Eastern, Southwest Asian Descent).
"The SCOLISCORE Test, along with other diagnostic testing and clinical examination, enables the physician to confidently recommend a personalized treatment regimen for each patient at the first sign of the disease," said John Climaco, president and chief executive officer of Axial Biotech. "SCOLISCORE and other tests in our product pipeline have the potential to completely transform treatment paradigms and ultimately to lead to improved and more efficient patient care."
The development of the SCOLISCORE Test required more than six years of development by Axial researchers and involved DNA samples collected from more than 9,500 individuals at more than 100 clinical sites throughout the world. SCOLISCORE utilizes 53 DNA markers found to be linked to the progressive form of scoliosis. To identify these DNA markers from nearly one million potential targets, Axial researchers leveraged its proprietary, world class genealogic database called GenDB, which contains information on more than 30 million ancestors and descendants of the original Utah pioneers. The test has been validated in three studies with approximately 800 patients with AIS.
"Axial is the first mover into molecular testing for spine disorders, representing a near-term opportunity that rivals the market size of diagnostics for breast cancer," added Climaco. "We have broken the code to scoliosis, and we are uncovering the important role genetics play in other spinal disorders. We are applying our research capability to identify genetic links that could potentially expand applications in scoliosis and also serve as a basis for a predictive test for the treatment of those suffering from degenerative disc disease."