- MSPrecise next generation sequencing assay
supports identification of multiple sclerosis patients with 84%
accuracy -
- Results from this study were not combined with
oligoclonal banding (OCB) -
- MSPrecise performs well in identifying MS among
a broad cohort of potential neurological diseases -
Amarantus Diagnostics, a neurology-focused diagnostics company
developing diagnostic tests for multiple sclerosis and Alzheimer's
disease and a wholly-owned subsidiary of Amarantus Bioscience
Holdings, Inc. (OTCQX:AMBS), announced the publication of data on
its next generation sequencing (NGS) molecular diagnostic test for
multiple sclerosis, MSPrecise®. The paper entitled, "MSPrecise: A
molecular diagnostic test for multiple sclerosis using next
generation sequencing," has been published in the Elsevier journal
GENE.
MSPrecise is a proprietary next-generation DNA sequencing (NGS)
assay for the identification of patients with relapsing-remitting
multiple sclerosis (RRMS). MSPrecise utilizes next-generation
sequencing to measure DNA mutations found in rearranged
immunoglobulin genes in immune cells isolated from cerebrospinal
fluid. A blood based version of the test is in development.
"Given the early misdiagnoses that often occur with multiple
sclerosis, physicians have an increasing need for new methods to
accurately diagnose their patients," said Colin Bier, Chief
Development Officer of Amarantus Diagnostics. "MSPrecise scoring is
a powerful approach to aid clinicians in this task. In this study
completed in 2013 and now reported in 'GENE,' there is an overall
MSPrecise accuracy of 84% in identifying RRMS patients or patients
that will develop RRMS, which represents a huge benefit to
physicians. In early 2015, Amarantus reported data from a later
study that showed a significant increase in the accuracy of
MSPrecise when adding oligoclonal banding (OCB) to the algorithm.
We intend to publish those data combining MSPrecise and OCB in the
near future."
Previous studies demonstrated that cerebrospinal fluid-derived
(CSF) B cells from early relapsing-remitting multiple sclerosis
(RRMS) patients that express a VH4 gene accumulate specific
replacement mutations that can be quantified as a score that
identifies such patients as having or likely to convert to RRMS.
Next-generation sequencing is an efficient method to obtain the
sequencing information required by this mutation scoring tool,
originally developed using the less clinically viable single-cell
Sanger sequencing. The clinical study detailed in this publication
was conducted analyzing the VH4 antibody gene repertoires in CSF
cell pellets to determine the accuracy of the MSPrecise diagnostic
test in identifying the presence of the RRMS-enriched mutation
pattern from patient cerebrospinal fluid B cells.
In this study, cerebrospinal fluid cell pellets were obtained
from 26 patients with other neurological disease (OND) and 13
patients with confirmed RRMS using next generation sequencing. VH4
gene segments were amplified, sequenced by next generation
sequencing, and analyzed for mutation score. The results of the
diagnostic testing with MSPrecise showed a sensitivity of 75% on
the RRMS cohort and a specificity of 88% on the OND cohort. The
study confirmed an 84% accuracy of MSPrecise in identifying RRMS
patients or patients that will develop RRMS. MSPrecise exhibits
good performance in identifying patients with RRMS irrespective of
the time a patient exhibited RRMS.
Gerald E. Commissiong, President & CEO of Amarantus
Bioscience Holdings, added, "Our immediate focus is to conduct a
CLIA-validation study in order to make the test commercially
available, and plans are being finalized in this regard. We also
plan to conduct future investigational studies to determine whether
MSPrecise scoring using NGS platforms may be utilized to identify
clinically isolated syndrome (CIS) patients who will convert to
RRMS. Additionally, a more expansive clinical study with a larger
patient cohort including several sub-cohorts of RRMS patients on
disease modifying therapies and OND patients is also planned."
For online access to the abstract, "MSPrecise: A molecular
diagnostic test for multiple sclerosis using next generation
sequencing," please click
http://www.ncbi.nlm.nih.gov/pubmed/26172868.
A recent article published in The Guardian titled, "MS: four in
five multiple sclerosis sufferers in UK are misdiagnosed,"
describes the critical unmet need of accurate and efficient MS
diagnosis. In the survey of over 1,000 MS patients, 81% reported
that they had at least once been misdiagnosed, with over 39% of
sufferers waiting more than a year for an accurate diagnosis. A
link to the article can be found here:
http://www.theguardian.com/society/2015/may/27/four-in-five-multiple-sclerosis-sufferers-in-uk-are-misdiagnosed.
There are approximately 2.5 million MS patients worldwide that
are currently being treated with over $14 billion in drugs.
Misdiagnosis rates of over 50% have been routinely reported as the
cost of each false positive diagnosis has grown to an estimated
$100,000 and $250,000 per patient. This is the basis for a
worldwide market estimated at over $2 billion, growing along with
the cost of MS therapy.
Amarantus BioScience Holdings previously disclosed that it is
exploring strategic options for Amarantus Diagnostics, including
the potential sale, co-development or spinoff opportunities, to
derive the full value from its neuro-diagnostics business.
About MSPrecise®
MSPrecise® is a proprietary next-generation DNA sequencing (NGS)
assay for the identification of patients with relapsing-remitting
multiple sclerosis (RRMS) at first clinical presentation. MSPrecise
utilizes next-generation sequencing to measure DNA mutations found
in rearranged immunoglobulin genes in immune cells initially
isolated from cerebrospinal fluid. MSPrecise would augment the
current standard of care for the diagnosis of multiple sclerosis by
providing a more accurate assessment of a patient's immune response
to a challenge within the central nervous system. This novel method
of measuring changes in adaptive human immunity may also be able to
discern individuals whose disease is more progressive and requires
more aggressive treatment.
About Amarantus BioScience Holdings, Inc.
Amarantus BioScience Holdings (OTCQX:AMBS) is a biotechnology
company developing treatments and diagnostics for diseases in the
areas of neurology and orphan diseases. AMBS' Therapeutics division
has development rights to eltoprazine, a small molecule currently
in a Phase 2b clinical program for Parkinson's disease
levodopa-induced dyskinesia and with the potential to expand into
adult ADHD and Alzheimer's aggression. The Company has an exclusive
worldwide license to intellectual property rights associated to
Engineered Skin Substitute (ESS), an orphan drug designated
autologous full thickness skin replacement product in development
for the treatment of severe burns currently preparing to enter
Phase 2 clinical studies. AMBS owns the intellectual property
rights to a therapeutic protein known as
mesencephalic-astrocyte-derived neurotrophic factor (MANF) and is
developing MANF as a treatment for orphan ophthalmic disorders,
initially in retinitis pigmentosa (RP). AMBS also owns the
discovery of neurotrophic factors (PhenoGuard™) that led to MANF's
discovery.
AMBS' Diagnostics division owns the rights to MSPrecise®, a
proprietary next-generation DNA sequencing (NGS) assay for the
identification of patients with relapsing-remitting multiple
sclerosis (RRMS), and has an exclusive worldwide license to the
Lymphocyte Proliferation test (LymPro Test®) for Alzheimer's
disease, which was developed by Prof. Thomas Arendt, Ph.D., from
the University of Leipzig, and owns further intellectual property
for the diagnosis of Parkinson's disease (NuroPro®).
For further information please visit www.Amarantus.com, or
connect with the Company on Facebook, LinkedIn, Twitter and
Google+.
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CONTACT: Investor and Media Contact:
Jenene Thomas
Jenene Thomas Communications, LLC
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T: (US) 908.938.1475
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