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FDA Clears C2N's PrecivityAD2 Alzheimer's Blood Test for Ages 40+

Published

21 August 2026

Topic

opportunities

◆ Sectors

Diagnostics

◆ Geography

United States

◆ Source

Read at clpmag.com →

◆ Verified

Fusion42 · 22 August 2026 · Fusion42 review

The FDA cleared C2N Diagnostics’ PrecivityAD2 Alzheimer’s blood test for use in adults aged 40 and older showing cognitive impairment signs, marking it as the first such FDA-cleared test for this younger symptomatic group. The test offers high predictive accuracy using mass spectrometry to identify amyloid pathology and aims to enable earlier diagnosis and clinical trial participation.

This Wire brief sits within Fusion42's coverage of Diagnostics, and 13 sources have reported it between 20 Aug 2026 and 26 Sep 2026.

◆ ◆ The Wire takeaway

You can now target earlier-stage Alzheimer’s patients aged 40-plus with validated diagnostic tools that clear the FDA. This opens paths into clinical care and trials by speeding diagnosis far ahead of symptom onset.

◆ Coverage

13 sources · first reported 20 Aug 2026 · latest 26 Sep 2026

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◆ Topics

Diagnosticsalzheimersblood-testFDA-clearancediagnosticsclinical-trialsbiomarkers