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FDA Clears PrecivityAD2 Alzheimer Blood Test for Symptomatic Patients 40 and Older

Published

21 August 2026

Topic

opportunities

Sectors

Diagnostics

Geography

United States

Source

Read at neurologylive.com

Verified

Fusion42 · 21 August 2026 · Fusion42 review

The FDA has cleared C2N Diagnostics' PrecivityAD2 blood test for diagnosing Alzheimer's disease in symptomatic adults aged 40 and older, extending biomarker confirmation to a younger population. The test uses mass spectrometry to measure plasma amyloid and tau protein levels, showing high predictive accuracy and supporting earlier diagnosis and clinical trial enrolment.

This Wire brief sits within Fusion42's coverage of Diagnostics, and 7 sources have reported it between 20 Aug 2026 and 21 Aug 2026.

◆ The Wire takeaway

You now have a new regulatory-approved tool for earlier Alzheimer's diagnosis in younger symptomatic patients, opening a market for improved clinical decision support and trial recruitment services. Deploy this test to gain an early mover advantage in rapid biomarker-based diagnostic workflows.

Coverage

7 sources · first reported 20 Aug 2026 · latest 21 Aug 2026

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Topics

Diagnosticsfda-clearancealzheimer-diseaseblood-testbiomarkersdiagnostics