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ScoliScore AIS Prognostic Test
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How The SCOLISCORE Test Works

How The SCOLISCORE Test Works 

Sample collection for AIS progression is quick, and can take place right in the physician’s office. Your child will be asked to provide a saliva sample, which will then be sent for analysis at a lab. From your child’s saliva, the lab will analyze their DNA for indicators associated with the likelihood for scoliosis progression. The SCOLISCORE Test has the ability to distinguish between patients who are likely to progress to a severe curve, and those who might not. The test performed on your child’s saliva is strictly confidential, and only your child’s physician will receive the results.

The SCOLISCORE test uses specific DNA markers to predict the likelihood that an AIS curve will progress.

Did You Know
  • The current clinical factors used to predict the likelihood of curve progression to the point of requiring surgery (a combination of age, Cobb angle, Risser score, and x-ray results) are observational
  • Less predictive than the SCOLISCORE Test and knowledge of the initial curve angle
 

Researchers identified 28 signs in DNA that an AIS curve will progress (progressive genes), and 25 signs in DNA that an AIS curve will not progress (protective genes).

  • Children with AIS have both sets of signs in their DNA.
  • The ratio of signs present in a DNA sample predicts the likelihood that the child’s curve will or won’t progress.
  • A validated algorithm generates a SCOLISCORE number unique to your child's individual genetic markers. This score is provided to his/her physician in a test report.

The ability of The SCOLISCORE Test to predict whether a curve will progress has been demonstrated in clinical studies involving multiple samples of children with AIS.8

Progression
Markers, that when positive, contribute to progression of the curve.
Protective
Markers, that when positive, protect against progression of the curve.
Algorithm
set of rules for solving a problem in a finite number of steps, as for finding the greatest common divisor.
Source: www.dictionary.com
 
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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.