C2N Diagnostics Expands Partnership with Washington University School of Medicine to Commercialize a Clinical Blood Test for Detection of Early Alzheimer’s Disease
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-Aβ® 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-Aβ® 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 SILK-Aβ® method.
“With a simplified SILK-Aβ® 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 for patients.”
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.