FDA clears C2N Diagnostics’ early Alzheimer’s assessment test

C2N’s Alzheimer’s test is the first to be FDA-cleared for use in patients as young as 40 who present with cognitive impairment symptoms.

C2N Diagnostics’ PrecivityAD2 test had secured US Food and Drug Administration (FDA) clearance, making it the first Alzheimer’s test to be cleared by the agency for use in patients as young as 40.

PrecivityAD2, a blood test, is indicated for use in adults aged 40 and above who present with symptoms of cognitive impairment who are undergoing evaluation for Alzheimer’s disease or other forms of cognitive decline.

Research indicates that approximately 20 million US adults aged 65 and older, along with thousands more between the ages of 45 and 65 are living with cognitive impairment and could benefit from an early Alzheimer’s diagnosis.

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