Axial Biotech launches DNA-based test for adolescent idiopathic scoliosis

Axial Biotech, Inc. has announced the commercial launch of a new DNA-based test that indicates the likelihood of progression to a severe curve for children diagnosed with Adolescent Idiopathic Scoliosis (AIS).

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(TM) AIS Prognostic Test.

Scoliosis is an abnormal curvature of the spine that affects two to three percent of the population, or an estimated 7 million people in the United States. Most often scoliosis is identified during school or sport screenings. Girls are eight times more likely than boys to have a curve progress to a point that treatment is required.

Currently, to determine whether or not a curve will progress patients are observed over a period of several years with the uncertainty of not knowing what the long-term outcome is likely to be. If the curve does continue to progress, the most widely accepted treatments are spinal bracing or ultimately spinal fusion surgery.

"For decades, spine surgeons have been looking for ways to determine which patients may progress and which may not," stated Ken Ward, M.D., Chief Scientific Officer 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."

ScoliScore(TM) 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 that the launch of ScoliScore(TM) 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," said Mr. Climaco.

The initial launch of the ScoliScore(TM) test will be to a small group of physicians in the U.S. 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, Inc. to sell and market ScoliScore(TM).