C2N Diagnostics announced that the Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its proprietary brain amyloidosis blood test to screen for risk of Alzheimer disease. If approved, it would be the first blood-based screening test to predict brain amyloid PET scan results in adults with memory complaints or dementia.
The blood-based in vitro test provides clinicians with initial screening information to determine the need for further diagnostic testing. The test combines into a ratio the concentration of amyloid beta isoforms Aβ42 and Aβ40 in human plasma; in clinical studies, a correlation between lower plasma Aβ42 and Aβ40 ratio and brain amyloidosis determined by amyloid PET scans has been demonstrated.
According to the Company, the 2-phase PARIS Study (Plasma Test for Amyloid Risk Screening) will assess the clinical diagnostic performance of the brain amyloidosis blood test in patients at high risk for Alzheimer disease.
“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,” stated Dr Joel Braunstein, CEO of C2N Diagnostics. “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.”
For more information visit C2Ndiagnostics.com.