C2N Diagnostics, LLC (C2N) today announced that it
has expanded its partnership with Washington University School of
Medicine (WUSM) in St. Louis. The objective of this collaboration is to
commercialize a clinical blood test for detecting the earliest stages of
Alzheimer's disease (AD) as well as mild cognitive impairment (MCI).
Under terms of the agreement, C2N has acquired the exclusive
worldwide commercial license rights to a suite of technologies developed
in the laboratories of Professors Randall Bateman, MD and David
Holtzman, MD, in the Department of Neurology at WUSM.
The licensed technologies build upon the Stable Isotope Labeling
Kinetics (SILK™) platform pioneered at WUSM and already marketed by C2N.
The new technologies enable a novel approach to measure the metabolism
of brain-derived proteins implicated in AD and MCI. For the first time,
instead of analyzing AD proteins in cerebrospinal fluid, it is now
possible to detect the same metabolic markers in patients' blood samples.
This capability has implications for the advancement of new treatments,
early prevention, and personal wellness. Alzheimer's is now one of the
major global healthcare concerns. Approximately 44 million people
currently have clinical AD. Millions more have MCI that places them at
high risk for progression to clinical AD. The number of cases of AD and
MCI are expected to increase sharply in the years ahead due to the aging
baby boomer population.
Pharmaceutical companies developing new drugs targeting AD increasingly
recognize that early intervention provides the greatest chance of
halting or reversing disease progression. Biomarkers are needed to
detect this early pathology, which can begin at least 15 years before
the onset of any clinical symptoms. At the same time, dynamic
biomarkers, like those offered by the SILK™ platform, may also track
treatment responses during the pre-symptomatic stages of disease.
Since 2008, C2N has applied the SILK-Aß® test to
measure the kinetics of beta-amyloid in cerebrospinal fluid. The test
has served as a primary endpoint in clinical drug studies to demonstrate
target engagement and guide dose selection. The SILK-Aß®
isoforms test is also highly sensitive to identifying people with brain
amyloidosis (one of the earliest indicators of AD), even before amyloid
deposits are seen with brain imaging. Still, the more invasive nature of
cerebrospinal fluid sampling has impeded the full potential of the
"With a siplified SILK-Aß® test available through blood
sampling, we now have an opportunity to validate a unique therapeutic
and diagnostic marker," stated Dr. Joel B. Braunstein, CEO of C2N.
"We plan to achieve this validation by collaborating with pharmaceutical
companies that are testing their compounds in phase 2 and phase 3
clinical studies, as well as by participating in natural history studies
tracking the progression of AD. If successful, we expect to be able to
offer a reliable and informative screening test that is also convenient
Alzheimer's Disease and Mild Cognitive Impairment
Data compiled by the Alzheimer's Association (alz.org)
estimate that currently 5 million Americans over the age of 65 suffer
from AD. As the population ages, this number is expected to increase to
7.1 million by the year 2025. While AD is the 5th leading
cause of mortality in the U.S. for those over age 65, it is the only
disease in the top 10 most prevalent diseases which has no known cure or
preventative agent. While deaths from AD have increased almost 70% in
the past decade, those from most other major diseases, including cancers
and heart disease, have decreased. Currently AD is diagnosed based on
clinical assessment by skilled neurologists or based on an amyloid
imaging brain scan: there are no approved blood based biomarkers for
this disease. Early detection of AD is a major research focus since
early detection would pave the way for early intervention. Mild
cognitive impairment (MCI) is often a precursor of clinical AD. The
disorder is associated with cognition changes that are serious enough to
be noticed by the individuals experiencing them or to other people, but
the changes are not severe enough to interfere with activities of daily
living. Individuals with MCI have a significantly increased risk of
eventually developing AD, with approximately 50% of such individuals
converting to AD within three years.
Dr. Randall Bateman and Dr. David Holtzman originally developed the
SILK™ technology at WUSM. Scientific American recognized the SILK-Aß®
assay as one of the top 50 new innovative technologies of the year.
Similar to a pulse chase assay, the SILK-Aß® assay relies on in
vivo labeling of human subjects with a stable isotope labeled amino
acid. The stable isotope labeled amino acid is non-radioactive, safe to
the environment and to humans, and is incorporated into newly generated
proteins. Using a highly sensitive mass spectrometer, we can measure the
incorporation of the stable isotope into Aß and thereby assess the
metabolism of Aß. This ability is particularly useful for early
detection of brain amyloidosis or when assessing the pharmacodynamic
effect of drugs that are hypothesized to alter the metabolism of Aß in
humans. With these new developments, we have expanded the use of the
assay to measuring Aß metabolism in plasma.
About C2N Diagnostics
C2N Diagnostics, LLC (www.c2ndiagnostics.com)
formed in late 2007 by scientific co-founders Drs. David Holtzman and
Randall Bateman of Washington University School of Medicine in St.
Louis, the Washington University Office of Technology Management, and
LifeTech Research, a Maryland-based technology research and
commercialization firm (www.lifetechresearch.com).
C2N is commercializing a suite of novel biomarker assays and
tools to assist in pre-clinical drug discovery, clinical drug
development, and the early detection and assessment of progression of
debilitating neurodegenerative disorders. The company's products include
the SILK-Aß®, SILK-ApoE™, SISAQ-Aß™, and SISAQ-Tau™ Assays,
which rely upon stable isotope labeling and tandem mass spectrometry for
the measurement of the kinetics, or in vivo metabolism, and absolute
quantitation of brain derived proteins. Beyond AD, products are in
development to target Parkinson's disease, Huntington's disease, brain
injury, schizophrenia and amyotrophic lateral sclerosis, among other
conditions. For additional information, please contact firstname.lastname@example.org
or call 1-877-C2N-DIAG (1-877-226-3424).
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