FDA Clears C2N Diagnostics’ PrecivityAD2, The First Alzheimer’s Blood Test For Adults With Cognitive Symptoms As Young As 40

The U.S. Food and Drug Administration (FDA) cleared C2N Diagnostics' PrecivityAD2 blood test for use in conjunction with a standard clinical evaluation to aid in identifying amyloid pathology associated with Alzheimer's disease. The FDA-cleared test is indicated for adults as young as 40 years. The FDA-cleared version is expected to become available later in 2026. C2N's current Clinical Laboratory Improvement Amendments (CLIA)-validated PrecivityAD2 test remains available through the company's clinical laboratory.

The test is intended for use with adults age 40 and older who have signs or symptoms of cognitive impairment and are . . .