ScoliScore™: New Genetic Test for Scoliosis

[Justin]

Press Releases

Axial Biotech Announces Commercial Availability of SCOLISCORE™ AIS Prognostic Test
The first marketed product of Axial’s pipeline of personalized diagnostics for spine disorders

AIS Prognostic Test, (September 24, 2009) — SALT LAKE CITY – September 24, 2009 -- Axial Biotech, Inc., a company personalizing spine care through the development of molecular diagnostics, announced today that its SCOLISCORE™ 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.”

About Axial Biotech
Axial Biotech, Inc. is advancing first-of-a-kind molecular diagnostics that answer key clinical questions in spine care, allowing for more accurate and personal treatment decisions for spine disorders. Axial markets the SCOLISCORE™ AIS Prognostic Test, the first and only test that utilizes the genetic blueprint of progressive scoliosis to enable physicians to identify which patients are likely to progress to a severe curvature. Using the same approach that led to the successful development of the SCOLISCORE AIS Prognostic Test, Axial is currently developing a predictive test for surgical outcomes for patients with degenerative disc disease. Axial is a privately held, venture-backed molecular diagnostics company founded in 2003 by a group of of internationally recognized spine surgeons and geneticists. More information is at Axial Biotech | Spinal Care Research Testing

About Axial Biotech
Axial Biotech, Inc. is a privately held, venture-backed company founded in 2002 by a group of internationally recognized spine surgeons and geneticists. The company is focused on developing and commercializing DNA-based pre-symptomatic and prognostic tests, as well as motion-preserving technologies, for common spinal disorders. The company's headquarters and laboratory are located in Salt Lake City, Utah


Media Contact:
Eric K. Olson
Executive Vice President Sales and Marketing
Axial Biotech, Inc.
801-984-9100 ext. 129
eolson (at) axialbiotech.com

[Justin]

ScoliScore™ AIS Prognostic Test

Now, there is a predictive test for children diagnosed with Adolescent Idiopathic Scoliosis (AIS) that provides increased peace of mind for patients, their families, and health care providers. This new molecular based test is called, ScoliScore™ AIS Prognostic Test.

ScoliScore™ is a clinically validated, multi-gene test that provides a qualitative and quantitative assessment of the likelihood of spinal curve progression for patients who have been diagnosed with AIS. The ScoliScore™ is leading the way to individualized scoliosis treatment by providing patient-specific information that is used to help health care providers optimize treatment plans.

The ScoliScore™ AIS Prognostic Test is intended for patients:

• With a primary diagnosis of (AIS)
• Between the ages of 9 and 13 years old
• With a mild scoliotic curve (defined as <25°), or
• With a moderate scoliotic curve (defined as >25°, but less than 40°)

The same pioneering, molecular research and product development that has been instrumental in developing the ScoliScore™ AIS Prognostic Test has also provided the foundation for other prognostic tests which are currently under development.

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