Full Press Release Details
Transgenomic Acquires ScoliScore
Adolescent Idiopathic Scoliosis
Prognostic Test from Axial Biotech
Commercially Established, Highly Accurate
Test Reduces Dangerous Radiation Exposure in Adolescents Diagnosed with Scoliosis
OMAHA, Neb. (August 28, 2012)
- Transgenomic, Inc. (OTCBB: TBIO) announced today that it has entered into a definitive agreement to acquire the global rights
to Axial Biotech's ScoliScore Adolescent Idiopathic Scoliosis (AIS) Prognostic Test for a total consideration of $4.4
million in cash. The acquisition provides Transgenomic with the ScoliScore assay technology and intellectual property, an
established revenue and customer base and access to a market estimated at 400,000 patients in the United States.
"The acquisition of ScoliScore
furthers Transgenomic's strategic vision of investing in products and technologies with significant potential or that can
benefit immediately from synergies available through our existing sales team, clinical laboratories and other infrastructure, including
relationships with Medicare, Medicaid and other third-party payers. We believe that ScoliScore will contribute positively
to earnings by the end of 2012, excluding any acquisition related charges," said Craig Tuttle, Chief Executive Officer of
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 adolescent children diagnosed with AIS, or an abnormal lateral curve of the spine. The ScoliScore
Test helps to reduce the uncertainty of AIS progression and may help patients reduce the need for repeated doctor visits, physical
examinations and years of exposure to radiation from frequent x-rays.
prevalent adolescent deformity. Every year, 100,000 adolescent children are diagnosed with AIS. Only 2-4 percent of these affected
children will progress to a severe spinal curve requiring surgical intervention. Despite this low rate of progression, adolescent
children with scoliosis are routinely monitored by numerous physician office visits and are subjected to a high number of x-ray
examinations. The ScoliScore Test identifies, with a high degree of accuracy, those individuals who are unlikely to progress
to a point where surgery is needed, which can significantly reduce their radiation exposure from repeated x-ray monitoring,"
commented Mr. Tuttle.
Ken Ward, MD, Chief Medical Officer of
Axial Biosciences added, "Diagnosing AIS is routine, but predicting which patients have severe disease and need to be closely
followed is challenging. ScoliScore enables physicians to more efficiently and effectively manage the long-term care of
adolescents with scoliosis. In a study completed by the National Cancer Institute, 5,466 women who had been monitored for Scoliosis
and were exposed to 25 or more x-rays during their adolescent years were followed into adulthood and experienced a 67 percent increase
in breast cancer death versus what you would expect in the normal population. The ScoliScore Test can predict, with a 99
percent accuracy rate, those subjects who will not progress to a severe curve, saving time, expense, patient and parent anxiety
and potentially harmful exposure to radiation. No other currently available method of AIS evaluation is as accurate and convenient
The transaction is subject to the approval
of Axial Biotech's shareholders and other conditions and is expected to close in September 2012.
More About ScoliScore and
Each year, 100,000 children between the
ages of 9 and 12 present to physicians with a mild AIS curve 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 radiographic monitoring that,
with the use of ScoliScore , may not be required.
Current methods for predicting curve progression
in AIS is 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 radiological exposure and unnecessary bracing for the ~75 percent of mild AIS patients
expected to be classified as low-risk by ScoliScore (i.e., <1 percent risk of progressing to a severe curve). For more
information about ScoliScore visit www.scoliscore.com.
About Transgenomic, Inc.
Transgenomic, Inc. (www.transgenomic.com)
is a global biotechnology company advancing personalized medicine in cardiology, oncology, and inherited diseases through its proprietary
molecular technologies and world-class clinical and research services. The Company is the global leader in cardiac genetic testing
with a family of innovative products, including its flagship C-GAAP test, designed to detect gene mutations which indicate cardiac
disorders, or which can lead to serious adverse events. Transgenomic has three complementary business divisions: Transgenomic Clinical
Laboratories, which specializes in molecular diagnostics for cardiology, oncology, neurology, and mitochondrial disorders; Transgenomic
Pharmacogenomic Services, a contract research laboratory that specializes in supporting all phases of pre-clinical and clinical
trials for oncology drugs in development; and Transgenomic Diagnostic Tools, which produces equipment, reagents, and other consumables
that empower clinical and research applications in molecular testing and cytogenetics. Transgenomic believes there is significant
opportunity for continued growth across all three businesses by leveraging their synergistic capabilities, technologies, and expertise.
The Company actively develops and acquires new technology and other intellectual property that strengthens its leadership in personalized
About Axial Biotech, Inc.
Axial Biotech is a privately held, venture-backed
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. The company's headquarters and laboratory
are located in Salt Lake City, UT. For more information about Axial Biotech visit the company's website at www.axialbiotech.com.
Forward-Looking Statements
Certain statements in this press release
constitute "forward-looking statements" of Transgenomic within the meaning of the Private Securities Litigation Reform
Act of 1995, which involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially
different from any future results, performance or achievements expressed or implied by such statements. Forward-looking statements
include, but are not limited to, those with respect to management's current views and estimates of future economic circumstances,
industry conditions, company performance and financial results, including the ability of the Company to grow its involvement in
the diagnostic products and services markets. The known risks, uncertainties and other factors affecting these forward-looking
statements are described from time to time in Transgenomic's filings with the Securities and Exchange Commission. Any change
in such factors, risks and uncertainties may cause the actual results, events and performance to differ materially from those referred
to in such statements. Accordingly, the Company claims the protection of the safe harbor for forward-looking statements contained
in the Private Securities Litigation Reform Act of 1995 with respect to all statements contained in this press release. All information
in this press release is as of the date of the release and Transgenomic does not undertake any duty to update this information,
including any forward-looking statements, unless required by law.
David Pitts, 212-600-1902