Axial Biotech

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Axial Biotech, Inc.
Company type Privately held
Founded2002;22 years ago (2002)
SLC, Utah, USA
Defunct2013;11 years ago (2013)
Headquarters
Website www.axialbiotech.com   OOjs UI icon edit-ltr-progressive.svg

Axial Biotech, Inc. was a privately held molecular diagnostics company based in Salt Lake City, Utah. [1] It was founded in 2002.

Contents

The company's mission was to deliver diagnostics that improve and personalize the treatment of spine disorders. Axial Biotech conducted genetic research on scoliosis and degenerative disc disease.

In September 2009, Axial Biotech announced the commercial launch of the ScoliScore AIS Prognostic Test with the claim of it being a DNA-based diagnostic test for scoliosis. In 2012 Transgenomic acquired the rights to the ScoliScore test. [2]

AIS genetic testing

AIS genetic testing is the process of analyzing the DNA of a patient who has been diagnosed with adolescent idiopathic scoliosis to determine his or her likelihood of progression to a severe spinal curve.

Approximately 4% of AIS patients will progress to the point where surgery is done. The majority of adolescents with idiopathic scoliosis are observed at regular intervals (usually between 4–6 months) with a physical exam and x-ray to evaluate the magnitude of the curve. [3]

Adolescent Idiopathic Scoliosis is a polygenic trait, meaning it is affected by the characteristics of more than a single gene. The heritability of scoliosis has long been suspected, and many research projects have been conducted in search of the genes responsible for the disease. [4]

Axial Biotech performed a genome-wide association study, testing millions of genetic markers to find any associated with scoliosis. The study of DNA heritability was enhanced through the use of rich genealogical data available in Utah. Over the course of the research, DNA samples from over 9500 patients from 100 clinical sites worldwide were analyzed. [5]

Researchers at Axial Biotech identified 53 genetic markers (28 which, when positive, contribute to the progression of the scoliosis curve and 25 which, when positive, protect against the progression of the curve.) [6] The ScoliScore test was developed around these 53 markers.

ScoliScore

ScoliScore AIS Prognostic Test is a genetic test that analyzes the DNA of patients who are diagnosed with Adolescent Idiopathic Scoliosis, the most common type of scoliosis. The test shows the likelihood of spinal curve progression. In other words, it helps doctors and patients to see how likely it is that a patient's spine will become more curved and whether it is likely that the patient will eventually need surgery or other interventions.

Approximately 85-90% of patients initially diagnosed with AIS will never have their mild scoliotic curve progress to a magnitude that requires surgical treatment. The test results may be used to predict, with over 99% probability, when a mild scoliotic curve is unlikely to progress to the point of requiring surgical treatment. This knowledge can make it unnecessary for these patients to undergo numerous office visits and be exposed to radiographic imaging over many years to monitor potential curve progression. A ScoliScore test is a powerful tool, which helps physicians predict spinal curvature through one test, accomplishing what was previously only possible through years of observation.

The test is distributed by DePuy Spine, a Johnson & Johnson company. [7] It was made available in a few physicians' offices in September 2009 and was commercially launched in 2010.

In 2012, Transgenomic acquired the rights to the ScoliScore test. [2]

Related Research Articles

<span class="mw-page-title-main">Scoliosis</span> Medical condition of the spine

Scoliosis is a condition in which a person's spine has an irregular curve. The curve is usually S- or C-shaped over three dimensions. In some, the degree of curve is stable, while in others, it increases over time. Mild scoliosis does not typically cause problems, but more severe cases can affect breathing and movement. Pain is usually present in adults, and can worsen with age. As the condition progresses, it may alter a person's life, and hence can also be considered a disability.

<span class="mw-page-title-main">Lumbar puncture</span> Procedure to collect cerebrospinal fluid

Lumbar puncture (LP), also known as a spinal tap, is a medical procedure in which a needle is inserted into the spinal canal, most commonly to collect cerebrospinal fluid (CSF) for diagnostic testing. The main reason for a lumbar puncture is to help diagnose diseases of the central nervous system, including the brain and spine. Examples of these conditions include meningitis and subarachnoid hemorrhage. It may also be used therapeutically in some conditions. Increased intracranial pressure is a contraindication, due to risk of brain matter being compressed and pushed toward the spine. Sometimes, lumbar puncture cannot be performed safely. It is regarded as a safe procedure, but post-dural-puncture headache is a common side effect if a small atraumatic needle is not used.

<span class="mw-page-title-main">Kyphosis</span> Medical condition

Kyphosis is an abnormally excessive convex curvature of the spine as it occurs in the thoracic and sacral regions. Abnormal inward concave lordotic curving of the cervical and lumbar regions of the spine is called lordosis. It can result from degenerative disc disease; developmental abnormalities, most commonly Scheuermann's disease; Copenhagen disease, osteoporosis with compression fractures of the vertebra; multiple myeloma; or trauma. A normal thoracic spine extends from the 1st thoracic to the 12th thoracic vertebra and should have a slight kyphotic angle, ranging from 20° to 45°. When the "roundness" of the upper spine increases past 45° it is called kyphosis or "hyperkyphosis". Scheuermann's kyphosis is the most classic form of hyperkyphosis and is the result of wedged vertebrae that develop during adolescence. The cause is not currently known and the condition appears to be multifactorial and is seen more frequently in males than females.

<span class="mw-page-title-main">Harrington rod</span> Surgical implant typically used to stabilise scoliosis

The Harrington rod is a stainless steel surgical device. Historically, this rod was implanted along the spinal column to treat, among other conditions, a lateral or coronal-plane curvature of the spine, or scoliosis. Up to one million people had Harrington rods implanted for scoliosis between the early 1960s and the late 1990s.

<span class="mw-page-title-main">Personalized medicine</span> Medical model that tailors medical practices to the individual patient

Personalized medicine, also referred to as precision medicine, is a medical model that separates people into different groups—with medical decisions, practices, interventions and/or products being tailored to the individual patient based on their predicted response or risk of disease. The terms personalized medicine, precision medicine, stratified medicine and P4 medicine are used interchangeably to describe this concept, though some authors and organizations differentiate between these expressions based on particular nuances. P4 is short for "predictive, preventive, personalized and participatory".

<span class="mw-page-title-main">Back brace</span> Corrective medical device worn around a patients back

A back brace is a device designed to limit the motion of the spine in cases of bone fracture or in post-operative spinal fusiona, as well as a preventative measure against some progressive conditions or to correct patient posture.

In medicine, a biomarker is a measurable indicator of the severity or presence of some disease state. It may be defined as a "cellular, biochemical or molecular alteration in cells, tissues or fluids that can be measured and evaluated to indicate normal biological processes, pathogenic processes, or pharmacological responses to a therapeutic intervention." More generally a biomarker is anything that can be used as an indicator of a particular disease state or some other physiological state of an organism. According to the WHO, the indicator may be chemical, physical, or biological in nature - and the measurement may be functional, physiological, biochemical, cellular, or molecular.

<span class="mw-page-title-main">Kyphoscoliosis</span> Medical condition

Kyphoscoliosis describes an abnormal curvature of the spine in both the coronal and sagittal planes. It is a combination of kyphosis and scoliosis. This musculoskeletal disorder often leads to other issues in patients, such as under-ventilation of lungs, pulmonary hypertension, difficulty in performing day-to-day activities, psychological issues emanating from anxiety about acceptance among peers, especially in young patients. It can also be seen in syringomyelia, Friedreich's ataxia, spina bifida, kyphoscoliotic Ehlers–Danlos syndrome (kEDS), and Duchenne muscular dystrophy due to asymmetric weakening of the paraspinal muscles.

<span class="mw-page-title-main">Scheuermann's disease</span> Medical condition

Scheuermann's disease is a self-limiting skeletal disorder of childhood. Scheuermann's disease describes a condition where the vertebrae grow unevenly with respect to the sagittal plane; that is, the posterior angle is often greater than the anterior. This uneven growth results in the signature "wedging" shape of the vertebrae, causing kyphosis. It is named after Danish surgeon Holger Scheuermann.

<span class="mw-page-title-main">Milwaukee brace</span>

The Milwaukee brace, also known as a cervico-thoraco-lumbo-sacral orthosis or CTLSO, is a back brace most often used in the treatment of spinal curvatures in children but also, more rarely, in adults to prevent collapse of the spine and associated pain and deformity. It is a full-torso brace that extends from the pelvis to the base of the skull. It was originally designed by Blount and Schmidt in 1946 for postoperative care when surgery required long periods of immobilization.

The Boston brace, a type of thoraco-lumbo-sacral-orthosis (TLSO), is a back brace used primarily for the treatment of idiopathic scoliosis in children. It was developed in 1972 by M.E "Bill" Miller and John Hall at the Boston Children's Hospital in Boston, Massachusetts.

<span class="mw-page-title-main">Spinal disease</span>

Spinal disease refers to a condition impairing the backbone. These include various diseases of the back or spine ("dorso-"), such as kyphosis. Dorsalgia refers to back pain. Some other spinal diseases include spinal muscular atrophy, ankylosing spondylitis, scoliosis, lumbar spinal stenosis, spina bifida, spinal tumors, osteoporosis and cauda equina syndrome.

<span class="mw-page-title-main">Scoliosis Research Society</span> International professional organization

The Scoliosis Research Society (SRS) is a non-profit, professional, international organization made up of physicians and allied health personnel, whose purpose is to "care for those with spinal deformity throughout life by patient care, education, research and patient advocacy." It was founded in 1966 with 37 members, and now has grown to include over 1300 spinal deformity surgeons and allied health personnel in 41 countries, with a primary focus on providing continuing medical education for health care professionals, and funding/support for research in spinal deformities. Among the founding members were Dr. Paul Randall Harrington, inventor of the Harrington rod treatment for scoliosis, and Dr. David B. Levine, spine surgeon at Hospital for Special Surgery. Harrington later served as President of the SRS from 1972 to 1973, and Levine was President of the Society from 1978 to 1979. Current membership primarily includes spinal deformity surgeons, as well as some researchers, physician assistants, and orthotists who are involved in research and treatment of spinal deformities. Strict membership criteria ensure that the individual SRS Fellows are dedicated to the highest standards of care for adult and pediatric spinal deformities, utilizing both non-operative and operative techniques.

<span class="mw-page-title-main">Neuromechanics of idiopathic scoliosis</span>

The neuromechanics of idiopathic scoliosis is about the changes in the bones, muscles and joints in cases of spinal deformity consisting of a lateral curvature scoliosis and a rotation of the vertebrae within the curve, that is not explained by either congenital vertebral abnormalities, or neuromuscular disorders such as muscular dystrophy. The idiopathic scoliosis accounts for 80–90% of scoliosis cases. Its pathogenesis is unknown. However, changes in the vestibular system, a lateral shift of the hand representation and abnormal variability of erector spinae motor map location in the motor cortex may be involved in this disease. A short spinal cord and associated nerve tensions has been proposed as a cause and model for idiopathic scoliosis. Besides idiopathic scoliosis being more frequent in certain families, it is suspected to be transmitted via autosomal dominant inheritance. Estrogens could also play a crucial part in the progression of idiopathic scoliosis through their roles in bone formation, growth, maturation and turnover. Finally, collagen, intervertebral disc and muscle abnormalities have been suggested as the cause in idiopathic scoliosis, although these are perhaps results rather than causes.

Lateral electrical surface stimulation is a neuromuscular stimulation treatment for idiopathic scoliosis. It is also known as the LESS treatment, and was invented by Dr. Jens Axelgaard in 1976. It is a non-invasive scoliosis treatment that utilizes electrical muscle stimulation, which is also known as neurostimulation or neuromuscular stimulation.

The management of scoliosis is complex and is determined primarily by the type of scoliosis encountered: syndromic, congenital, neuromuscular, or idiopathic. Treatment options for idiopathic scoliosis are determined in part by the severity of the curvature and skeletal maturity, which together help predict the likelihood of progression. Non-surgical treatment should be pro-active with intervention performed early as "Best results were obtained in 10-25 degrees scoliosis which is a good indication to start therapy before more structural changes within the spine establish." Treatment options have historically been categorized under the following types:

  1. Observation
  2. Bracing
  3. Specialized physical therapy
  4. Surgery

Anterior vertebral body tethering (AVBT) is a relatively new surgery for the treatment of scoliosis in pediatric patients. Left untreated, severe scoliosis can worsen and eventually affect a person's lungs and heart.

The Providence brace is a nighttime spinal orthosis for the treatment of adolescent idiopathic scoliosis (AIS). The brace is used to curb the natural progression of the disease and prevent further curvature of the AIS patient's spine. The Providence brace was developed by Charles d'Amato and Barry McCoy, and is manufactured by Spinal Technology, Inc.

<span class="mw-page-title-main">Adolescent idiopathic scoliosis</span> Medical condition

Adolescent idiopathic scoliosis (AIS) is a disorder in which the spine starts abnormally curving sideways (scoliosis) between the ages of 10–18 years old. Generally, AIS occurs during the growth spurt associated with adolescence. In some teens, the curvature is progressive, meaning that it gets worse over time, however, AIS more commonly manifests only as a mild curvature.

Pierre Stagnara was a French spinal surgeon. He has been described as a "pioneer" in the study of spinal deformities, "one of the greatest figures of French spinal surgery." Stagnara was born in January 16, 1917 in Loriol-sur-Drôme, France. He studied medicine in the city of Lyon. During World War II he was drafted into the French army. After the war, he worked in a variety of hospitals throughout Lyon. In 1959 he became the Chief of the Centre des Massues and served in this position until his retirement in 1982. Whilst working at the institution he pioneered many orthopedic techniques. Including the non-surgical management of scoliosis.

References

  1. "Axial raises $15.3 million in second financing round". Deseret News . March 28, 2007. Archived from the original on October 18, 2012. Retrieved October 15, 2009.
  2. 1 2 "Transgenomic Acquires ScoliScore Adolescent Idiopathic Scoliosis Prognostic Test from Axial Biotech". Businessweek. Bloomberg. August 28, 2012. Retrieved April 20, 2014.
  3. Kuivala, Thomas, M.D. "What You Need to Know About Scoliosis." 1/17/08 Spine Universe. 2009 "What You Need to Know About Scoliosis". Archived from the original on January 16, 2010. Retrieved May 8, 2012.
  4. Ward K, Ogilvie J, Argyle V, Nelson L, Meade M, and Braun J. "Polygenic Inheritance of Adolescent Idiopathic Scoliosis: A Study of Extended Families in Utah" 2008
  5. "Axial Biotech Announces Commercial Availability of SCOLISCORE AIS Prognostic Test" Press Release. September 24, 2009
  6. M. Stenning, I. Nelson (2011). "Recent advances in the treatment of scoliosis in children". British Editorial Society of Bone and Joint Surgery. Retrieved January 1, 2014.
  7. "Genetic markers for scoliosis are ID'd". Deseret News . September 14, 2008. Archived from the original on July 28, 2012. Retrieved October 15, 2009.