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Adolescent Idiopathic Scoliosis and GeneticsWhat Is The ScoliScore TestHow The SCOLISCORE Test WorksPatient Resources
ScoliScore AIS Prognostic Test
Clinical Test Development
Demonstrated Accuracy
Predicting the Likelihood of Progression
What Is The SCOLISCORE Test

What is the SCOLISCORE Test

The SCOLISCORE Test PackageThe SCOLISCORE Test is the first and only genetic test proven to give physicians and parents insight into the possible progression of your child’s Adolescent Idiopathic Scoliosis (AIS), thereby reducing the uncertainty of AIS progression, and allowing for a more personalized treatment plan for your child. 

The SCOLISCORE Test helps to reduce the uncertainty of AIS progression and provides information to your child’s physician to aid in a personalized treatment plan for your child.

  • The SCOLISCORE Test is performed by collecting a saliva sample during a physician’s office visit. The sample is then sent to a laboratory for analysis.
  • Within two to three weeks of the laboratory receiving the sample, the SCOLISCORE Test report form will be sent to your child’s physician.
  • The SCOLISCORE Test assigns a numerical value (between 1 and 200) to the likelihood of curve progression based on your child’s DNA and current Cobb angle.
  • The physician can then use this information, combined with other clinical factors, to determine a personalized treatment plan for your child.
  • All patient results are kept confidential and are not distributed by the laboratory to anyone other than the ordering physician.
  • Is performed by a state-of-the-art laboratory regulated under and by the Clinical Laboratory Improvement Amendments (CLIA) of 1988.


The SCOLISCORE Test is appropriate for:

Indications
  • Adolescent Idiopathic Scoliosis
  • Ages 9-13 years
  • Self reported Caucasian males and females (North American, South American, European, Eastern European, Middle Eastern)
  • Mild Curve (10° - 25° Cobb angle)


This test should be administered prior to beginning scoliosis treatment, since the SCOLISCORE Test may help physicians make more informed decisions about how to manage your child's curve.

 
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The SCOLISCORE AIS Prognostic Test was designed and validated by Axial Biotech, Inc.
and is co-marketed and sold by both DePuy Spine, Inc. and Smith & Nephew, Inc.

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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°). 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.

Caution:
The SCOLISCORE™ Test is designed to accurately predict the likelihood of severe curve progression for patients diagnosed with Mild AIS and who received a SCOLISCORE in the Low Risk Classification (1- 50). Therefore, care should be exercised when utilizing the risk of progression for patients in the Intermediate Risk (51 � 179) and High Risk Classifications (180 � 200). The SCOLISCORE Test information should always be interpreted with all other clinical factors when determining the appropriate clinical treatment and care of patients. Under Federal law, this test may only be performed on the order of a physician and its results may only reported to the ordering physician.

DEPUY SPINE™, the DePuy Spine logo and SCOLISCORE™ are trademarks of DePuy Spine, Inc.