C2N Launches Trial for Alzheimer ’s Detection Test
C2N Diagnostics is experiencing a couple of breakthroughs with its Alzheimerâs 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.
âA 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,â Dr. Joel Braunstein, CEO of C2N Diagnostics, said in a release. âThe best chance we have for treating Alzheimerâs Disease will come from earlier detection and, thus, earlier intervention. A simple, safe blood-based screening test woul...
Source: MDDI - Category: Medical Devices Authors: Omar Ford Tags: IVD Source Type: news
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