C2N Diagnostics, LLC has established itself as a leading innovator in the field of high-performance blood biomarkers to aid in the early diagnosis of Alzheimer’s disease (AD). In 2020, the Company introduced the first analytically and clinically validated blood biomarker – the PrecivityAD® test – for use in clinical care within the United States. During mid-2023, C2N introduced into clinical care the first p-tau217 (%p-tau217, p-tau217/np-tau217) assay as part of a second-generation test, PrecivityAD2™, that combined Aβ42/40 and %p-tau217 into a validated algorithm, achieving clinical diagnostic performance comparable to the current gold standards of amyloid PET and CSF biomarkers. Precivity™ related markers have been used extensively in a variety of clinical research applications throughout the world, with evidence from multiple studies demonstrating their high performance.

C2N seeks to demonstrate the scalability of high-resolution mass spectrometry and sample processing, beyond C2N’s central CAP-CLIA, ISO13485:2016 clinical laboratory located in St. Louis, MO, USA. C2N believes that a scalable, decentralized solution for high-performance testing is a requisite to address the expected major future global demand for early and accurate disease detection. Early and accurate detection represents an essential step for transforming the trajectory of AD through early treatment and, ultimately, prevention. 

In this project, C2N aims to develop and validate a clinical lab workstation along with Precivity™ diagnostic test kits to enable a globally accessible test solution for use in the routine clinical evaluation of individuals with cognitive impairment.