C2N Diagnostics is experiencing a couple of breakthroughs with its Alzheimer’s disease detection test - one courtesy of FDA. The agency, which is slowly rising back to full strength after the temporary government shutdown, granted the St. Louis-based company breakthrough device designation for a brain amyloidosis blood test.
In addition, C2N said it is launching its Plasma Test for Amyloid Risk Screening (PARIS) Study that is evaluating and validating the clinical diagnostic performance of the C2N brain amyloidosis blood test.
The company said the C2N test is a blood-based in vitro diagnostic being developed to predict amyloid PET scan results. It combines into a ratio the concentration of amyloid beta (Aβ) isoforms Aβ42 and Aβ40 in human plasma, as measured by mass spectrometry. The firm said studies have demonstrated that a lower plasma Aβ42/Aβ40 ratio correlates with brain amyloidosis determined by amyloid PET scans.
“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,” Dr. Joel Braunstein, CEO of C2N Diagnostics, said in a release. “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. At C2N, we are making strong progress toward these goals and are committed to introducing a test that is widely accessible.”
There have been numerous methods aimed at Alzheimer’s disease and cognitive decline in patients. Late last year, researchers from Brigham and Women’s Hospital revealed work on a test that can detect tau protein, a calling card for Alzheimer’s disease.
In 2017, a Canadian medical software developer rolled out an electronic version of simple screening application for dementia called Braintest, for iPads and Android tablets.