C2N Diagnostics has announced that it has expanded its partnership with Washington University School of Medicine (WUSM) in St Louis, USA. The objective of this collaboration is to commercialise a clinical blood test for detecting the earliest stages of Alzheimer’s disease as well as mild cognitive impairment. 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 and David Holtzman in the Department of Neurology at WUSM.
The licensed technologies build upon the Stable Isotope Labelling 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 Alzheimer’s disease and mild cognitive impairment. For the first time, instead of analysing Alzheimer’s disease 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 Alzheimer’s disease. Millions more have mild cognitive impairment that places them at high risk for progression to clinical Alzheimer’s disease. The number of cases of Alzheimer’s disease and mild cognitive impairment are expected to increase sharply in the years ahead due to the aging baby boomer population.
Pharmaceutical companies developing new drugs targeting Alzheimer’s disease increasingly recognise 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 Alzheimer’s disease), 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,” states Joel B Braunstein, chief executive officer 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 Alzheimer’s disease. If successful, we expect to be able to offer a reliable and informative screening test that is also convenient for patients.”