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Cologuard

FDA PMA

Class III (US FDA PMA)

PMA P130017

by Exact Sciences Corporation

Identity

Trade Name
COLOGUARD FDA PMA
Generic Name
System, colorectal neoplasia, DNA methylation and hemoglobin detection FDA PMA

Identifiers

PMA Number
P130017 FDA PMA
FDA Product Code
PHP FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Pathology FDA PMA
FDA Decision
APPR Approved FDA PMA

The Cologuard system is a device for the qualitative detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool. It is intended to screen adults of either sex, 50 years or older, who are at typical average-risk for colorectal cancer (CRC). A positive result may indicate the presence of CRC or advanced adenoma and should be followed by diagnostic colonoscopy. Cologuard is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.

Cologuard is authorized by the FDA and is supplied as a system for colorectal neoplasia detection. The system is indicated for use in adults 50 years or older, and it is not intended for use in high-risk individuals. The device is a DNA methylation and hemoglobin detection system, and it is classified as a class 3 device.

Frequently asked questions

What is Cologuard used for?

Cologuard is used for the qualitative detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool, to screen adults 50 years or older who are at average-risk for colorectal cancer.

Is Cologuard a replacement for diagnostic colonoscopy?

No, Cologuard is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. A positive result from Cologuard should be followed by diagnostic colonoscopy.

What is the intended population for Cologuard?

Cologuard is intended for use in adults of either sex, 50 years or older, who are at typical average-risk for colorectal cancer.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Cologuard® test | Exact Sciences, Exact Sciences: Cancer Prevention, Screening & Therapy ..., [PDF] cologuard-plus-clinician-brochure.pdf - Exact Sciences, Sign Up | Cologuard® Screening Solutions, Always delivering: UPS® and the Cologuard® test

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Exact Sciences Corporation

Sources (1)

  • FDA PMA P130017 24 fields · synced Sep 18, 2026