It is a clinically validated, multigene test that provides a qualitative and quantitative assessment of the likelihood of spinal curve progression for patients who have been diagnosed with AIS. The test is paving the way for individualized scoliosis treatment by providing patient-specific information that is used to help healthcare providers optimize evidence-based recommendations for treatment options.
The scoliosis research leading to the test involved collecting DNA samples from >9000 patients from 85 clinical sites worldwide. All patient samples were analyzed on several technology platforms and specific disease classifications were evaluated by the review of X-rays and medical records provided from physicians who were treating enrolled study patients. The ScoliScore AIS Prognostic Test is intended for patients aged between 9 and 13 with a primary diagnosis of AIS and with a mild scoliotic curve (defined as <25°) or with a moderate scoliotic curve (defined as >25° but <40°).
In addition to the test, DNA-based diagnostics/prognostics for other spinal disorders products are currently in development by Axial Biotech including genetic tests for early onset of severe degenerative disc disease, spondyloslisthesis Scheuermann's disease, osteoarthritis, and osteoporosis.
Founded in 2002 by spine surgeons and geneticists, the company has raised $28 million in venture financing including a series B financing led by Johnson & Johnson Development Corp (the venture capital subsidiary of Johnson & Johnson), with participation by vSpring Capital and Ohio Biotech Group; Medtronic is also an early investor in Axial Biotech, which uses a proprietary database of 23 million birth, death, and marriage records of the descendants of the original Mormon pioneers to facilitate the identification of disease-causing changes in the human genome.