C2N Diagnostics received FDA clearance for the PrecivityAD2 blood test.
Published
Signal category
Legal & Regulatory
Quote
“C2N is honored to see Newsweek spotlight the FDA‑cleared PrecivityAD2® test”
— C2N Diagnostics team
Company
C2N Diagnostics
Fierce Medtech named C2N one of its Fierce 15 for 2020; "one of the most promising private companies in the industry.”
- Industry
- Biotechnology Research
- Location
- St Louis, US
- Company size
- 112 employees
C₂N Diagnostics’ vision is to bring Clarity Through Innovation™. It focuses its therapeutic discovery efforts around mechanism-based approaches to prevent or stop the progression of human neurological disorders. Diagnostic efforts revolve around bringing accurate, widely accessible, and cost-effective blood tests to the clinic for the betterment of patient care and brain health monitoring. Its lead commercial product, the PrecivityAD™ blood test, is a mass spectrometry-based test performed in C₂N’s CLIA-certified lab that measures in blood multiple analytes including Aβ42, Aβ40, and apolipoprotein E isoforms. While the test by itself cannot diagnose Alzheimer’s disease — which is a clinical diagnosis made by a health care provider — the test is an important new tool for physicians to aid in the evaluation process. PrecivityAD™, which can only be ordered through a health care provider, predicts brain amyloid plaques as determined by PET scan results and in 2019 it received a Breakthrough Device Designation from the U.S. Food and Drug Administration. The PrecivityAD™ blood test also has achieved the CE Mark from the European Union. For more information visit www.C2N.com.
Founded 2007