Transgenomic Acquires Saliva-Based Genetic Test for Prognosis of Scoliosis

Transgenomic has completed its acquisition of Axial Biotech’s ScoliScore™ Adolescent Idiopathic Scoliosis (AIS) Prognostic Test. The acquisition provides Transgenomic with the ScoliScore™ assay technology and intellectual property, an established revenue and customer base, and access to a testing market estimated at 400,000 patients in the United States alone.

Each year, 100,000 children between the ages of 9 and 12, present to physicians with a mild AIS (curvature of less than or equal to 10 degrees). Approximately 2-4 percent will eventually experience curve progression necessitating an instrumented fusion procedure. This means that approximately 96,000-98,000 of these newly diagnosed patients will not progress to a curve requiring instrumented fusion. As a result of the inability to predict which patients will require surgical intervention and which will not, a large majority of patients undergo medical and X-Ray monitoring that may not be required. Use of ScoliScore™ could minimize this unnecessary testing.


Current methods for predicting curve progression in AIS are limited. The ScoliScore™ AIS Prognostic Test was developed and validated using data generated from thousands of AIS patients. The ScoliScore™ AIS Test offers clinicians a new and highly accurate method for evaluating the risk of curve progression that enables a substantial reduction in X-Ray exposure and unnecessary bracing for the 75 percent of mild AIS patients expected to be classified as low-risk by ScoliScore™.


ScoliScore™ is the first clinically validated and commercially available saliva-based multi-gene test that provides a highly accurate assessment of the likelihood of spinal curve progression for individuals diagnosed with AIS, or an abnormal lateral curve of the spine. The ScoliScore™ Test identifies patients that will not progress to a severe curvature of the spine and reduces those patients’ need for repeated doctor visits, physical examinations and, most importantly, years of exposure to radiation from frequent X-Rays.

“Using a simple saliva test, ScoliScore™ can predict, with 99 percent accuracy, those patients that will not progress to having a severe spinal curve. No other method of AIS evaluation is as accurate and convenient,” said Craig Tuttle, Chief Executive Officer of Transgenomic. “Yet this advantage is not just about convenience and safety. The health economic benefits of the ScoliScore™ Test are considerable for patients, physicians, and payors, when taking into account the time and expense associated with repeated radiography and the costs related to treating AIS. ScoliScore™ is emblematic of the kind of value-added, proprietary genetic test on which Transgenomic is built.”