• Center on Health Equity & Access
  • Clinical
  • Health Care Cost
  • Health Care Delivery
  • Insurance
  • Policy
  • Technology
  • Value-Based Care

Cologuard Receives FDA Nod for CRC Diagnosis

Article

Cologuard had received recommendation for premarket approval from a FDA advisory panel back in March.

The US Food and Drug Administration (FDA) today approved Cologuard (Exact Sciences Corporation), a stool-based colorectal cancer (CRC) in vitro diagnostic device.

Cologuard analyzes stool specimens to detect hemoglobin, multiple DNA methylation and mutational markers, and the total amount of human DNA contained in cells that are shed by CRC or advanced adenomas into the colon.

The test is intended to be used as an adjunctive screening test to detect colorectal neoplasia-associated DNA markers and the presence of occult hemoglobin in human stool. A positive test result may indicate the presence of CRC or premalignant colorectal neoplasia. The device is not meant to be a replacement for colonoscopy and is intended to be used in conjunction with colonoscopy and other test methods according to recognized screening guidelines.

Read the original report: http://bit.ly/1r6NS0v

Source: Medscape

Related Videos
Wanmei Ou, PhD, vice president of product, data analytics, and AI at Ontada
Glenn Balasky, executive director of the Rocky Mountain Cancer Center.
Corey McEwen, PharmD, MS
dr linda bosserman
dr andrew leitner
Glenn Balasky during a video interview
dr joseph alvarnas
dr joseph alvarnas
Related Content
© 2024 MJH Life Sciences
AJMC®
All rights reserved.