C2N Diagnostics LLC

C2N Diagnostics LLC Profile last edited on: 6/18/2021 4041 Forest Park Avenue Saint Louis, MO 63108    (314) 633-1886    info@c2ndiagnostics.com    www.c2ndiagnostics.com

Business Identifier: Assays to assist in neurodegenerative disease diagnosis and drug discovery

Public Profile:
Based on technology developed within the neuroscience laboratories of Washington University School of Medicine, Saint Louis, MO, LifeTech Research, Inc. of Baltimore MD co-founded C2N Diagnostics. In late January 2019, U.S. Food and Drug Administration (FDA) granted a Breakthrough Device Designation for C2N's proprietary brain amyloidosis blood test. This test will be used to screen for brain amyloid pathology in individuals being assessed for an Alzheimer's Disease diagnosis. To qualify for the FDA's Breakthrough Device Program, a medical device must provide more effective diagnosis or treatment of a life-threatening or irreversibly debilitating condition, among other criteria. This program is designed to expedite the development and review of such medical devices. The core competency of C2N Diagnostics is study of the metabolism of neurally derived biomolecules intended to catalyze important new therapeutic and diagnostic discovery efforts directed toward disorders characterized by mishandled proteins and other biomolecules within the brain. C2N Diagnostics, LLC is developing a suite of biomarker assays and tools to assist in pre-clinical drug discovery, clinical drug development, and the early detection and assessment of progression of debilitating neurodegenerative disorders. The company’s first commercial tool, the SILK-Aß™ assay, relies on stable isotope labeling and tandem mass spectrometry for the precise measurement of the kinetics, or in vivo metabolism, of amyloid-beta – a small peptide implicated as a key mediator of Alzheimer’s disease. Other products are in development to target Parkinson’s disease, Huntington’s disease, schizophrenia, and amyotrophic lateral sclerosis (ALS), among others.