• ADOLESCENT IDIOPATHIC
  SCOLIOSIS AND GENETICS
• WHAT IS THE
  SCOLISCORE TEST
• HOW THE SCOLISCORE
  TEST WORKS

ScoliScore > What is the ScoliScore Test

New Saliva Test Helps Predict If Scoliosis Will Get Worse
ScoliScore™ Prognostic AIS Test May Reduce Frequent X-Rays and Doctor Visits For Low Risk Patients

The ScoliScore™ Test is the first clinical test to help doctors determine which children diagnosed with mild adolescent idiopathic scoliosis (AIS) are least likely to progress to a severe curve. Saliva samples are analyzed for genetic risk factors or DNA markers that have been discovered to be linked to progression of scoliosis.

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

The ScoliScore™ Test is intended for Caucasian children between age 9 and 13 diagnosed with mild adolescent idiopathic scoliosis (AIS). The ScoliScore™ Test results can help doctors understand the likelihood of curve progression, but does not identify which treatments to use. Test results should be used with other diagnostic information to help the patient and doctor determine the best course of action.

What makes the ScoliScore™ Test unique from other forms of genetic testing?

The ScoliScore™ Test is the first commercially available genetic test for a spine deformity. Unlike other kinds of genetic testing, the ScoliScore™ Test helps predict severity of the condition once it is diagnosed. It does not predict an individual's susceptibility to inherit the condition.

• 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)

How important an advancement is it?

The ScoliScore™ Test is an important advancement in the care of scoliosis because, until now, there was no clinically reliable way to predict which patients with mild AIS curves would progress to a severe curve and which would not. As a result, all scoliosis patients were monitored in the same fashion as though they all were candidates for developing a severe curve, which requires months or even years of follow up.

What is the potential impact that the ScoliScore™ Test will have on scoliosis diagnosis and treatment?

The ScoliScore™ Test results can help doctors understand the likelihood of curve progression but does not identify which treatment to use. Combined with traditional diagnostic information, the ScoliScore™ Test results may provide more informed, personalized treatment plans for patients. A low curve progression score may reduce the frequency or extent of repetitive patient monitoring, such as x-rays and clinical examinations for low risk patients. The result should be interpreted in the context of all other diagnostic information to help the patient and doctor determine the best treatment option.

The ScoliScore™ Test should be administered by Schumacher Chiropractic Clinics, P.A. prior to beginning scoliosis treatment, since the ScoliScore™ Test may help doctors make more informed decisions about how to manage your child's curve.

What to expect with the ScoliScore™ AIS Prognostic Test?

The ScoliScore™ Test helps to reduce the uncertainty of AIS progression and provides information to your child's doctor to aid in a personalized treatment plan.

• The ScoliScore™ Test is performed by collecting a saliva sample during a doctor's visit to Schumacher Chiropractic Clinics. 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 doctor.
• The ScoliScore™ Test assigns a numerical value to the likelihood of curve progression based on your child's DNA and current curve size.
• The doctor can then use this information, combined with other clinical factors, to determine a personalized treatment plan for your child.
• All individual test results are kept confidential and are not distributed by the laboratory or Schumacher Chiropractic Clinics, P.A., to anyone other than the ordering doctor.

How much does the test cost and is it covered by insurance?

The ScoliScore™ Test costs $2,950 and is likely to be covered by insurance because the test utilizes well established Diagnostic CPT codes. Our office charges a $50 fee to administer the test. Patients should check with their insurance providers to determine individual coverage. The Axial Biotech Reimbursement Team is also available to help verify whether someone's healthcare insurance covers the test and to make the insurance billing process as easy as possible for doctors.

Do you have questions about scoliosis screening or administering the ScoliScore™ AIS Prognostic Test? Please call us, we will be happy to assist you.

Schumacher Chiropractic Clinics, P.A. 

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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.

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 be reported to the ordering physician.