FDA Issues Breakthrough Designation for Alzheimer’s Test

The FDA granted C2N Diagnostics breakthrough designation for its blood-based amyloidosis diagnostic test, which assesses a patient’s risk for Alzheimer’s disease.

The screening test will help doctors determine the need for further diagnostic testing using positron emission tomography. Amyloid PET scans accurately detect amyloid plaques, a hallmark of Alzheimer’s.

“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,” said C2N’s CEO Joel Braunstein.