Aug. 25, 2026—The FDA has cleared C2N Diagnostics’ PrecivityAD2 test, indicated for use in adults aged 40 years and older who present with signs or symptoms of cognitive impairment undergoing evaluation for Alzheimer’s disease or other forms of cognitive decline. The test is intended to be used in conjunction with clinical assessment to aid health care professionals experienced in the evaluation of cognitive impairment to identify patients with amyloid pathology associated with Alzheimer’s disease. It is not intended as a screening or standalone diagnostic test.
The PrecivityAD2 testing platform uses high-resolution mass spectrometry to simultaneously quantify multiple specific plasma beta/β-amyloid and tau peptide isoforms in the blood, expressing the values as the Aβ42/40 ratio and p-tau217/np-tau217 ratio. The two ratios are combined into a proprietary statistical algorithm to calculate an amyloid probability score 2 ranging from zero to 100 to identify the likelihood of amyloid pathology associated with Alzheimer’s disease.
The FDA-cleared version of the test is expected to be available later this year; the CLIA-validated test is available through C2N’s clinical laboratory.