SALT LAKE CITY, July 6, 2011 /PRNewswire/ — As part of its ongoing efforts to improve the quality of care and to moderate healthcare costs for patients diagnosed with scoliosis, Axial Biotech, Inc., a company revolutionizing spine care through the development of molecular diagnostic technologies, today announced that it has signed a multi-year agreement with the Shriners Hospitals for Children®.
The agreement focuses on providing access to the SCOLISCORE™ AIS Prognostic Test to patients diagnosed with Adolescent Idiopathic Scoliosis and meet the appropriate indications for use*, regardless of their ability to pay for the test. The agreement applies to all of the Shriners Hospitals for Children® in the United States, Canada and Mexico.
When a child is diagnosed with mild AIS, an abnormal curvature of the spine, it is often difficult for physicians to predict if the curve will progress to a more severe form of the condition, which may require surgery or other treatments. Now, the SCOLISCORE Test is helping to reduce the uncertainty of whether or not a curve will progress to a curve larger than 40 degrees, considered possibly needing a fusion, and may help low-risk patients reduce the need for repeated doctor visits, physical examinations, and years of frequent x-rays.
The SCOLISCORE Test was developed by utilizing a genome-wide association study that identified a panel of genetic markers associated with severe curve progression. The scoliosis research used in the development of this test included collecting DNA samples from over 10,000 patients from over 100 IRB approved clinical sites throughout the world. The test was then further validated in three separate clinical trials.
“This is a significant corporate commitment on our part to provide the SCOLISCORE Test to assist many of the Shriners patients,” said John Climaco, Axial Biotech’s President and CEO. “We fully support the mission of the Shriners Hospitals for Children®, and realize that the hospitals are funded by individual donors who have provided charitable donations to allow children access to medical care, who would otherwise not be able to receive it. Because of this, we felt we needed to act to do our part to provide access to this innovative technology.”
The SCOLISCORE Test is currently offered at more than 150 spine centers in the U.S., and is co-marketed by DePuy Spine, Inc. and Smith & Nephew. For more information, please contact Axial Biotech’s Customer Service at 877-AXIAL98 (877-294-2598) or visit the company’s website, www.axialbiotech.com, or www.scoliscore.com.
About Axial Biotech, Inc.
Axial Biotech, Inc. is the leading developer of molecular diagnostics for common spinal diseases and 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. Axial is accredited by the College of American Pathologists (CAP) and is certified to comply with the Clinical Laboratory Improvement Amendments (CLIA). Axial is a privately held, venture-backed molecular diagnostics company founded in 2002 by a group of internationally recognized spine surgeons and geneticists. The company is based in Salt Lake City, Utah.
About Shriners Hospitals for Children®
Shriners Hospitals for Children® is a one-of-a kind pediatric hospital system dedicated to improving the lives of children through innovative research, education and specialized treatment of orthopaedic conditions, burns, spinal cord injuries and cleft lip and palate. With 22 hospitals in the U.S., Canada and Mexico, Shriners Hospitals for Children is committed to providing expert, family-centered care regardless of the patients’ ability to pay and relies on the generosity of donors to deliver this mission every day. To support Shriners Hospitals for Children®, call 1.800.241.GIFT or go to www.donate2shc.org. Visitwww.shrinershospitals.org for more information.
*Indications for Use:
The SCOLISCORE™ AIS Prognostic Test is intended for in vitro use only. The SCOLISCORE Test is indicated for Caucasian, adolescent males and females between the ages of 9-13 years with a mild curve (Cobb angle 10-25 degrees). This test utilizes DNA extracted from a saliva specimen in a polymerase chain reaction to detect the genotypes for genetic markers found in clinical trials to be associated with severe curve progression in patients diagnosed with Adolescent Idiopathic Scoliosis (AIS). Results from the SCOLISCORE Test are intended for use as an adjunct to existing clinical and radiologic information to determine the risk of curve progression. For additional information regarding indications for use, please see the SCOLISCORE Test package insert.
SCOLISCORE™ is a trademark of DePuy Spine, Inc.