Scoliscore

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The Scoliscore Genetic Test

Scoliscore is a new genetic test that predicts the likelihood of curve progression in patients diagnosed with Adolescent Idiopathic Scoliosis (AIS). It is available at Spine Correction Center.

Researchers at Axial Biotech developed the Scoliscore Prognostic Test, which uses a patient’s saliva to identify 53 different genetic markers that have been shown in clinical trials to predict the likelihood of curve progression. The result of the Scoliscore Test serves is a guide for health care providers to optimize the treatment of scoliosis.

Criteria for using the Scoliscore Test are:

  • patients with newly diagnosed AIS
  • between the ages of 9 and 13 years
  • with a spinal curve of 10 to 25 degrees

Since a person’s DNA does not change, the test is only given once.

The Scoliscore Test has a 99% Negative Predictive Value. (A Negative Predictive Value refers to the probability that a patient with a negative test result is free of the condition for which the test was conducted.)

The Scoliscore Test is a breakthrough that allows us to safely and effectively identify the genetic component that may play a role in scoliosis. Scoliosis is a multi-factorial disease that is basically broken down into genetic and environmental factors. By understanding the genetic component, it allows us to guide treatment more effectively.

- Dr. Michael Farrell

A scoliosis patient provides a saliva sample that is sent to Axial Biotech’s laboratory in Salt Lake City, Utah. The results of the test are available in approximately 2 to 3 weeks with the results given to the patient by the health care provider that ordered the test.

The score is set in a range from 1 to 200. The range is further broken into risk categories of low, intermediate and high. An individualized scoliosis treatment plan, can be developed by better understanding the likelihood of risk progression, provide by the Scoliscore Test. Many treatment options are available, including an Early Stage Scoliosis Treatment (ESST) Protocol that was developed by the CLEAR Institute, a non-profit group from Minnesota.

Dr. Farrell, D.C. further explains that, “For a patient that has a high Scoliscore, indicating a scoliosis condition that has a high genetic propensity, we may refer that patient to a spinal surgeon for a surgery consultation but still enroll them into an aggressive ESSI protocol. For patients who have a low Scoliscore, it means the patient has a low genetic propensity for progression. That effectively allows us to treat their condition via the environmental factors that also can cause scoliosis progression. It is important to note that both examples need their scoliosis treated, but their treatment protocols may be vastly different.”

Axial Biotech uses well-established molecular diagnostic CPT codes when billing for the Scoliscore Test. Insurance companies recognize these codes and have paid the vast majority of insurance claims. For patients with no insurance or limited income, help might be available through Axial Biotech’s SHARP Patient Assistance Program. Information about financial help for patient’s families to pay for Scoliscore Tests can be found on their web site at www.axialbiotech.com or by calling (877) 742-7710.

Axial Biotech is a privately held company founded in 2002 by a group of internationally recognized spine surgeons and geneticists. Axial Biotech is focused on developing and commercializing genetic tests and treatment solutions for spinal disorders.

Scoliscore FAQ

We would like to help you understand your options when dealing with this diagnosis. Our patients have found the following information helpful. We hope you will read on.

Q: What is the SCOLISCORE Test?
A: The SCOLISCORE Test is the first and only genetic test proven to give doctors insight into the possible progression of your child’s Adolescent Idiopathic Scoliosis (AIS).

Q: How does the SCOLISCORE Test work?
A: The SCOLISCORE Test is a laboratory test performed on your child’s DNA from a saliva sample obtained in a doctor’s office. The SCOLISCORE Test looks for specific signs in DNA that suggest whether a curve may progress.

Q: When should the SCOLISCORE Test be used?
A: The SCOLISCORE Test is appropriate for Caucasian males and females between the ages of 9 -13 years who have recently been diagnosed with AIS and have a mild curve (Cobb angle 10° to 25°). This test should be administered prior to beginning scoliosis treatment, since the SCOLISCORE Test may help doctors make more informed decisions about how to manage your child’s curve.

Q: What are the benefits of the SCOLISCORE Test?
A: The SCOLISCORE Test provides greater insight into the likelihood that your child’s curve will progress to a severe curve >40º or not. When combined with existing radiographic and clinical information, the SCOLISCORE Test allows for personalized patient care decisions.

Q: Can the SCOLISCORE Test be used for other types of scoliosis?
A: The SCOLISCORE Test is intended only for patients who have been diagnosed with Adolescent Idiopathic Scoliosis. It is not intended for patients who have been diagnosed with Congenital, Infantile, Juvenile, or Adult Scoliosis.

Q: How do I get the SCOLISCORE Test for my child?
A: The SCOLISCORE Test can only be ordered by an authorized healthcare professional, typically your child’s treating doctor.

Q: What type of sample is needed to perform the SCOLISCORE Test?
A: The SCOLISCORE Test is performed by collecting a saliva sample during a visit to the doctor’s office. Your child will not need to have blood drawn for the test results.

Q: How long will it take to get the results of the SCOLISCORE Test?
A: It will typically take 2-3 weeks from the date the sample is received by Axial Biotech Laboratories for the results to be available. The SCOLISCORE Test report form is sent directly to the doctor treating your child.

Q: What are the results of the SCOLISCORE Test?
A: The SCOLISCORE Test provides your child’s doctor with a score from 1-200. This score accurately corresponds to the low, intermediate, or high likelihood of your child’s curve progressing to one greater than 40º.

Q: Will the SCOLISCORE Test results tell my doctor which treatment to use?
A: The results of the SCOLISCORE Test can help your doctor understand how likely your child’s curve is to progress or not, but the test will not specifically identify which treatments to use. The results of the SCOLISCORE Test should be used with other diagnostic information to help you and your doctor determine which treatment option is best for your child.

Q: Is the SCOLISCORE Test covered by insurance?
A: Many insurance carriers will cover the SCOLISCORE Test, but some carriers have yet to establish coverage policies. Please call our office for answers specific to your situation.

(Sources: http://www.treatingscoliosis.com/, http://www.scoliscore.com/)

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