Genetic Testing For Adolescent Scoliosis

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SALT LAKE CITY, Dec. 9 /PRNewswire/ -- Axial Biotech, Inc. announced

today 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 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 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.

Climaco, CEO and President of Axial Biotech, said that 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, " said Mr. Climaco.

The initial launch of the ScoliScore 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.

For more information on the ScoliScore test, please contact Axial

Biotech Customer Service at 877-AXIAL98 () or visit the

company's website at www.axialbiotech.com <http://www.axialbiotech.com/>