Identity
- Trade Name
- Multi-Target Stool DNA (mtsDNA) Test, Cologuard Plus FDA PMA
- Generic Name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection FDA PMA
Identifiers
- PMA Number
- P230043 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 Plus System is a qualitative in vitro diagnostic test designed for the detection of colorectal neoplasia-associated DNA methylation markers and occult hemoglobin in human stool samples. Classified as a Class III device, it aids in screening for colorectal cancer and advanced precancerous lesions by analyzing biomarkers collected via the Cologuard Plus Collection Kit.
This test is performed centrally at Exact Sciences in Madison, Wisconsin, using samples obtained from adults aged 45 and older at average risk for colorectal cancer. It is intended for screening purposes only and is not a substitute for diagnostic colonoscopy in high-risk individuals. The system operates under FDA Premarket Approval (PMA P230043) and is supplied as a kit-based diagnostic solution.
Frequently asked questions
What age group is the Cologuard Plus test designed for, and what is its primary purpose?
The Cologuard Plus test is designed for adults aged 45 and older who are at average risk for colorectal cancer. Its primary purpose is to screen for colorectal cancer and advanced precancerous lesions by detecting DNA methylation markers and occult hemoglobin in stool samples. It is not intended for high-risk individuals and is not a substitute for diagnostic colonoscopy.
How is the Cologuard Plus test administered, and where are the samples analyzed?
The Cologuard Plus test uses the Cologuard Plus Collection Kit to obtain stool samples from patients. These samples are then sent to Exact Sciences in Madison, Wisconsin, where the test is performed centrally to detect colorectal neoplasia-associated biomarkers.
Is the Cologuard Plus test a single-use or reusable system, and how is it supplied?
The Cologuard Plus is supplied as a kit-based diagnostic solution, meaning each test is performed using a new collection kit designed for single-use. The kit includes everything needed to collect the stool sample for analysis.
What does a positive result on the Cologuard Plus test indicate, and what follow-up is recommended?
A positive result on the Cologuard Plus test may indicate the presence of colorectal cancer or advanced precancerous lesions. Follow-up with a colonoscopy is strongly recommended for further diagnostic evaluation, as the test is intended for screening purposes only.
What regulatory pathway does the Cologuard Plus test follow, and who is the manufacturer?
The Cologuard Plus test follows the FDA Premarket Approval (PMA) pathway, with the approval number P230043. The manufacturer is Exact Sciences Corporation, based in Madison, Wisconsin.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P230043 | Class III | Active |
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Manufacturer
- Manufacturer
- Exact Sciences Corporation
Sources (1)
- FDA PMA P230043 24 fields · synced Sep 18, 2026