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.
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