A company that already seems to be on the fast track to making a difference in the lives of patients with spinal disorders just entered a collaboration that its president/CEO believes will put it on an even faster track to success.

In December Axial Biotech (Salt Lake City), a private company founded roughly six years ago, launched its first product, a predictive test designed for children diagnosed with adolescent idiopathic scoliosis (AIS), and expects the test to be available nationwide this fall. Now, to further accelerate its success, Axial has entered into a collaboration with the University of Utah (also Salt Lake City) that allows Axial access to the university's genetic resources including the Utah Population Database (UPDB).

"In a short amount of time we were able to crack the genetic code to progressive scoliosis using our GenDB database," said John Climaco, president/CEO of Axial. "Through the mapping of a disease passed on from family member to family member, The university's datasets further accelerate our ability to identify and validate genetic markers that can be used to develop diagnostic tests that allow for a more personalized and a more accurate approach to spine care."

Climaco told Medical Device Daily that the UPDB has medical histories associated with it so it makes the patient collection and sampling process much easier and "streamlines the product development process."

Composed of more than 6 million records, Axial says the UPDB provides "a rich source of information for genetic, epidemiological, demographic and public health studies which can be used to identify familial clusters of disease including spinal disorders." The company said that the UPDB combined with its GenDB genealogical database will help Axial researchers expand the indications and patient population for the ScoliScore AIS prognostic test. According to the company, the test is the first molecular diagnostic to determine a person's risk of progressive scoliosis.

The ScoliScore is designed to predict the likelihood of progression to a severe curvature in children diagnosed with AIS, Climaco said. He said many kids diagnosed with AIS undergo a high rate of X-ray exposure unnecessarily because their condition will never progress or require treatment. That's why he said it is so important to find out early on which child will progress to scoliosis and which child won't.

"That's what ScoliScore provides. It really opens the door to truly personalized care ..." because each child given the test receives an individual ScoliScore which correlates to their personal percentage of risk of progressing to scoliosis, Climaco said. It allows the child's physician to appropriately adjust the level of care for that particular child, he said.

Even in the short amount of time since Axial launched the ScoliScore, Climaco said the test is already making a difference. "We're already seeing physicians make those kinds of decisions, take the ScoliScore and say when I get a ScoliScore of 10', let's say, I don't need to see this child four times a year, I don't need to X-ray this child as I might have otherwise.'"

Climaco called this a "groundbreaking change" that is "very different than what has been the standard of care."

The collaboration will not only help Axial researchers expand the indications and patient population for the ScoliScore test, Climaco told MDD, it will also help the company expand the development of additional personalized tests for scoliosis, degenerative disc disease and other spine disorders.

"Access to both the UPDB and GenDB databases is a powerful resource for Axial," said Kenneth Ward, MD, Axial's CSO and chairman. "With a robust library of family histories and linked diseases at our finger tips, we aim to define the genetic makeup of spinal disorders in an effort to develop diagnostic and prognostic tests that can enable the medical community to provide more personalized spine care."

The UPDB is a University of Utah resource that makes available large datasets and multi-generation pedigrees to support research projects. The central component of the UPDB is an extensive set of Utah family histories, in which family members are linked to demographic and medical information.

Axial says Utah has an ideal population of extended families with multiple generations whose medical histories can be used to quickly determine heritability of complex diseases. As a result of high rates of immigration to Utah from a broad array of ethnic backgrounds, the heterogeneity allows for population studies representative of the general population of the U.S.

"Our partnership with Axial is an example of the expanding capabilities of our genetic assets," said Brian Cummings, director of the Technology Commercialization Office for the University of Utah. "We look forward to a long term partnership with such a strong local company and helping Axial further its position in the diagnostics of spinal disorders."

GenDB, Axial's genealogical database, has already been used to develop the ScoliScore test. GenDB contains multi-generational genealogical records of more than 30 million ancestors and descendants of the original Utah pioneers, the company noted. The database and software allow for a retrievable format for assembling family pedigrees. According to Axial, GenDB has "dramatically accelerated" the product development process and is being used to develop additional scoliosis products and a product line for adult degenerative disc disease.