Upstate Medical University

CNYBAC Client Quadrant Biosciences Receives FDA Designation as a "Breakthrough Device" for Clarifi ASD

Provided by Richard Uhlig, CEO Quadrant Biosciences

FDA has designated Quadrant Biosciences Clarifi ASD Test a "Breakthrough Device.”  Clarifi ASD is the world's first molecular test to facilitate the early diagnosis of Autism Spectrum Disorder and represents the most recent evolution of the pioneering research led by our friends and colleagues Frank Middleton, PhD (SUNY Upstate) and Steve Hicks, MD PhD (Penn State College of Medicine); their thought leadership in application of epigenetics in neuroscience is unrivaled.  

The FDA's very selective Breakthrough Devices Program is a voluntary program for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.  The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the FDA's mission to protect and promote public health.