FDA Awards Breakthrough Status to Blood Test to Determine Alzheimer’s Risk

C₂N Diagnostics announced that the U.S. Food and Drug Administration (FDA) has granted a Breakthrough Device Designation for C₂N’s proprietary brain amyloidosis blood test. This test will be used to screen for brain amyloid pathology in individuals being assessed for an Alzheimer’s Disease diagnosis. To qualify for the FDA’s Breakthrough Device Program, a medical device must provide more effective diagnosis or treatment of a life-threatening or irreversibly debilitating condition, among other criteria. This program is designed to expedite the development and review of such medical devices.
 
C₂N also reported the launch of its pivotal PARIS Study (Plasma Test for Amyloid Risk Screening), a clinical trial that is evaluating and validating the clinical diagnostic performance of the C₂N brain amyloidosis blood test. If approved by the FDA, the C₂N test could become the first blood-based screening test to predict brain amyloid PET scan results in adults with memory complaints or dementia. The test will provide initial screening information to help doctors determine the need for further diagnostic testing.
 
Currently, tests that detect Alzheimer’s Disease pathology in the brains of living people have significant limitations. Amyloid PET imaging is costly, a difficult procedure to access, and exposes individuals who do not have Alzheimer’s Disease to unnecessary radiation. Cerebrospinal fluid biomarkers require a spinal tap, a needle insertion into the lower part of the back. Dr. Joel Braunstein, CEO of C₂N Diagnostics, stated, “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. At C₂N, we are making strong progress toward these goals and are committed to introducing a test that is widely accessible.”
 
The C₂N test could also accelerate the development of new drugs for Alzheimer’s Disease. “Recruitment of individuals into Alzheimer’s Disease clinical trials is a time-consuming and expensive process because as many as 80 percent of candidates fail to meet inclusion criteria,” said Dr. Ilana Fogelman, VP of Clinical and Regulatory Affairs. “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.”