C2N Diagnostics has received breakthrough device designation from the US Food and Drug Administration (FDA) for its brain amyloidosis blood test to screen Alzheimer’s disease risk.
The in-vitro test is designed to screen for brain amyloid pathology in people who are undergoing Alzheimer’s diagnosis.
It is being developed to predict the results of amyloid PET scans, which are known to detect amyloid plaques, one of the biomarkers of the neurodegenerative disease.
C2N Diagnostics CEO Joel Braunstein said: “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.”
The company has initiated a pivotal trial, PARIS Study, to assess and validate the clinical diagnostic performance of the brain amyloidosis blood test.
The C2N test is expected to provide doctors with initial screening information to determine the requirement for further diagnostic testing.
Furthermore, the test has the potential to accelerate the development of new Alzheimer’s therapies by aiding in pre-selection of relevant trial participants.
C2N Diagnostics Clinical and Regulatory Affairs vice-president Dr Ilana Fogelman said: “Recruitment of individuals into Alzheimer’s disease clinical trials is a time-consuming and expensive process because as many as 80% of candidates fail to meet inclusion criteria.
“A screening test that pre-selects trial candidates more likely to have brain amyloidosis could decrease the screen failure rate and the overall time and cost of developing effective drugs for Alzheimer’s disease.”
If the FDA approves the diagnostic, it could be the first blood screening test to predict brain amyloid PET scan results in adults suffering from memory complaints or dementia, the company added.