The PrecivityAD™ Blood Test: A Precise, Robust LC-MS/MS Method to Identify Brain Amyloid Pathology in Patients with Mild Cognitive Impairment

The World Alzheimer's Report estimates that ~50M people live with dementia, of which Alzheimer's disease (AD) represents approximately 60-80% of all cases. Early diagnosis is imperative for early treatment and prevention, which offer the greatest chances for changing the future trajectory of AD. An urgent medical need exists for accurate, simple, lower-cost, radiation-free, and widely accessible blood-based tests to improve the diagnostic evaluation of patients with memory impairment and at risk for AD. A blood-based test (PrecivityAD™) was introduced into the clinic in 2020 as a CLIA-certified laboratory developed test performed by C2N Diagnostics. The test relies on LC-MS/MS to measure in plasma amyloid beta (Aβ) protein isoforms Aβ42 and Aβ40 and detect the presence of Apolipoprotein E (ApoE)-specific peptides. The data strongly support the test's role as a clinically useful tool to identify brain amyloid pathology, as well as its role in aiding the AD diagnostic evaluation process among individuals presenting to their clinicians with cognitive impairment.