C2N Diagnostics is a molecular diagnostics company aiming to transform the early diagnosis and early treatment of Alzheimer’s disease and related forms of neurodegeneration.

We were formed by scientific co-founders Drs. David Holtzman and Randall Bateman of Washington University School of Medicine in St. Louis, and LifeTech Research, a Maryland-based technology research and commercialization firm. Our CLIA certified clinical laboratory and research laboratory are based in St. Louis, MO.

Our core technology relies on state-of-the art mass spectrometry-based approaches to identify and quantify protein biomarkers that are important in the diagnosis, progression and treatment monitoring of human brain disorders.

We have developed a novel blood-based, in vitro diagnostic laboratory-developed test (LTD) for brain amyloid detection, a pathologic hallmark of Alzheimer’s disease. We offer the test under CLIA in most of the US and a CE Mark in the European Union. We are further developing and validating this test for FDA approval under FDA’s Breakthrough Devices Designation Program, with the goal of filling a major unmet medical need for a simple, widely accessible, and minimally invasive test to aid in Alzheimer’s diagnosis.

Our protein biomarkers are used in numerous collaborations throughout the world with leading academic investigators and also biopharmaceutical partners. Applications of our biomarkers include: accelerating the speed, lowering the cost, and improving the efficiency of enrolling individuals into clinical trials; informing researchers about the mechanism of action and biological activity of new treatments in clinical development; and following novel treatment responses.

Overview of the PrecivityAD Test for Healthcare Providers