C2N Diagnostics, a company engaged in commercializing a suite of biomarker tests to enable early detection of debilitating neurodegenerative disorders, has commenced the clinical study to assess the efficacy of its brain amyloidosis blood test.
The pivotal plasma test for amyloid risk screening (PARIS) study will assess and validate the clinical diagnostic performance of the C2N brain amyloidosis blood test.
C2N test is a blood-based in vitro diagnostic being developed to predict amyloid PET scan results, and it aggregates into a ratio the concentration of amyloid beta (Aβ) isoforms Aβ42 and Aβ40 in human plasma, as measured by mass spectrometry.
Amyloid PET scans are said to correctly detect amyloid plaques, which is a major symptom of Alzheimer’s disease. The C2N test is also expected to enhance the development of new drugs for Alzheimer’s disease.
The company has secured breakthrough device designation from the US Food and Drug Administration (FDA) for the brain amyloidosis blood test, which will help screen for brain amyloid pathology in individuals being evaluated for an Alzheimer’s disease diagnosis.
C2N test will turn as the first blood-based screening test to predict brain amyloid PET scan results in adults with memory complaints or dementia, if it secures approval from the FDA.
The test will offer initial screening information, enabling doctors determining the requirement for further diagnostic testing.
According to the company, amyloid PET imaging is costly and exposes individuals who do not have Alzheimer’s disease to unnecessary radiation.
Cerebrospinal fluid biomarkers need a spinal tap, a needle insertion into the lower part of the back.
C2N Diagnostics CEO Dr Joel Braunstein said: A vital medical need exists for a simple, radiation-free, non-invasive, less costly diagnostic test for the initial broad screening of individuals with subjective memory concerns. The best chance we have for treating Alzheimer’s disease will come from earlier detection and, thus, earlier intervention.
“A simple, safe blood-based screening test would be the first step in a multistage Alzheimer’s Disease diagnostic process. It would improve the speed and efficiency of the overall diagnostic process, and also afford significant cost savings to healthcare systems.”