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FDA clears C2N Diagnostics' early Alzheimer's assessment test
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Fusion42 · 21 August 2026 · Fusion42 review
The US FDA has cleared C2N Diagnostics' PrecivityAD2 blood test for early Alzheimer's assessment in adults aged 40 and older with cognitive impairment symptoms, marking the first such approval for patients as young as 40. The test quantifies amyloid and tau protein biomarkers to aid clinical evaluation of Alzheimer's disease alongside existing diagnostic pathways.
This Wire brief sits within Fusion42's coverage of Diagnostics, and 5 sources have reported it between 20 Aug 2026 and 21 Aug 2026.
◆ ◆ The Wire takeaway
You can enter the early Alzheimer's diagnostic market with a clinically cleared blood test now approved for younger adults, opening opportunities to partner with health systems simplifying complex memory diagnostics. This clearance tightens competition with Roche and signals growing acceptance of biomarker blood tests beyond standard imaging.
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5 sources · first reported 20 Aug 2026 · latest 21 Aug 2026
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