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FDA clears C2N Diagnostics' PrecivityAD2 blood test for Alzheimer's diagnosis in adults aged 40+

Published

20 August 2026

Topic

opportunities

Sectors

Digital Health

Geography

United States

Source

Read at app.dealroom.co

Verified

Fusion42 · 20 August 2026 · Fusion42 review

The US FDA has cleared C2N Diagnostics' PrecivityAD2 blood test for diagnosing Alzheimer's disease in adults aged 40 and older with cognitive symptoms, marking the first FDA-cleared diagnostic for this age group. The test uses high-resolution mass spectrometry to measure amyloid and tau proteins, showing high predictive values in clinical trials, and is expected to become available later this year.

This Wire brief sits within Fusion42's coverage of Digital Health, and 3 sources have reported it.

◆ The Wire takeaway

You face a new path to market in Alzheimer's diagnosis with FDA clearance extending to younger adults. Now is the time to engage healthcare providers and plan to integrate blood-based diagnostics into cognitive care offerings.

Coverage

3 sources · 20 Aug 2026

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Topics

Digital HealthFDA-approvalalzheimersdiagnosticsblood-testclinical-validation