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

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 13 sources have reported it between 20 Aug 2026 and 26 Sep 2026.