FDA Clears Ground-Breaking Alzheimer’s Test by Cortex District Company C2N Diagnostics

The U.S. Food & Drug Administration (FDA) has cleared C2N Diagnostics’ PrecivityAD2® test, providing patients and health care professionals with an accurate, accessible, and scalable blood test to help diagnose Alzheimer’s disease in conjunction with standard clinical workup. An estimated 19-20 million U.S. adults aged 65 and older, and hundreds of thousands more between ages 45 and 65 are living with cognitive impairment and may benefit from an early diagnosis[1].

The PrecivityAD2® FDA-cleared test version is expected to be available later this year; the current CLIA-validated, PrecivityAD2® test offering remains available through C2N’s clinical laboratory.