Cologuard / Cologuard Plus

by Exact Sciences  · Based in United States → — Screen with the leading noninvasive colon cancer test in the privacy of your home.
Gastroenterology Laboratory Medicine Oncology
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Most insured patients pay $0
Regulatory Status Disclosed

Overview

Cologuard and Cologuard Plus are FDA-approved, non-invasive stool DNA colorectal cancer screening tests developed by Exact Sciences. Cologuard is for average-risk individuals aged 45 and older. Cologuard Plus offers enhanced accuracy and fewer false positives compared to the original Cologuard test. These at-home collection kits are designed to detect colorectal neoplasia-associated DNA markers and occult hemoglobin in human stool, helping to find colon cancer in its early stages when it is more treatable. The tests are not a replacement for diagnostic colonoscopy in high-risk individuals. Exact Sciences aims to make colorectal cancer screening accessible, with most insured patients paying $0 out-of-pocket. The company also provides resources and support for both patients and healthcare providers, including information on ordering, returning kits, understanding results, and insurance coverage.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Non-invasive at-home stool collection
  • FDA-approved for average-risk individuals 45+
  • Detects colorectal neoplasia-associated DNA markers and occult hemoglobin
  • No bowel preparation required
  • No diet restrictions
  • No sedation needed
  • Enhanced accuracy and reduced false positives (Cologuard Plus)
  • Results typically available within 8-10 days
  • Supported by ExactNexusu2122 technology platform for seamless ordering and results
  • Multilingual support for instructions and customer care

Use Cases

  • Colorectal cancer screening for average-risk individuals aged 45 and older
  • Early detection of colorectal cancer
  • Detection of advanced precancerous lesions

What Physicians Need to Know

Polyp Detection During Colonoscopy
Cologuard is a stool-based test designed for colorectal cancer screening, not for real-time polyp detection during a colonoscopy. While it can detect some advanced precancerous lesions, its sensitivity for detecting polyps is significantly lower than that of a colonoscopy. Cologuard detects approximately 42% of large precancerous polyps, whereas a colonoscopy detects around 95% of large polyps. A positive Cologuard result necessitates a follow-up colonoscopy for definitive diagnosis and polyp removal.
GI Pathology Analysis
Cologuard analyzes stool samples for abnormal DNA markers and the presence of occult hemoglobin (blood). This multi-marker approach helps detect DNA alterations from cancerous and precancerous cells shed into human waste. The test results are binary (positive or negative) and indicate the potential presence of colorectal cancer or advanced adenoma, but do not provide detailed pathological analysis. A positive result requires a follow-up colonoscopy for definitive diagnosis and pathological assessment.
IBD Assessment Tools
Cologuard is not indicated for individuals with inflammatory bowel disease (IBD), including Crohn's disease or ulcerative colitis, as these conditions are associated with a high risk for colorectal cancer and require different screening and surveillance strategies.
Procedure Documentation
Cologuard is an at-home stool collection test. The kit includes instructions for collecting the sample, which involves using a bracket to fit a container over the toilet, collecting an entire bowel movement, taking a small sample with a probe, and adding preservative liquid. The collected sample is then shipped to a lab for analysis. Results are typically available within 8 to 10 days and are sent to the healthcare provider.
Quality Metrics Tracking
Cologuard is included in major colorectal cancer screening guidelines and quality measures, such as those from the USPSTF and ACS. A negative Cologuard result is recommended to be followed by rescreening every three years. The test can receive three years of Healthcare Effectiveness Data and Information Set (HEDISu00ae) quality credit. Studies have shown that Cologuard use contributes to an increase in colon cancer screening rates. Quality improvement initiatives have demonstrated improvements in Cologuard order and completion rates, leading to an increase in overall CRC screening rates. There is also a quality measure that tracks the percentage of patients with a positive stool-based test (including Cologuard) who complete a colonoscopy within 180 days.
Physician Tip

Cologuard is a valuable non-invasive screening option for average-risk individuals aged 45 and older. It is crucial to emphasize to patients that Cologuard is a *screening* test for cancer detection and not a *preventative* tool like a colonoscopy, which can detect and remove precancerous polyps. A positive Cologuard result *always* requires a follow-up diagnostic colonoscopy for definitive diagnosis and potential intervention. Educate patients on the limitations of Cologuard, particularly its lower sensitivity for polyp detection compared to colonoscopy, and the potential for false positives and false negatives. Ensure patients understand that Cologuard is not appropriate for high-risk individuals, including those with a personal or family history of colorectal cancer, a history of adenomas, or inflammatory bowel disease. Regular adherence to the recommended 3-year screening interval for negative Cologuard results is important for its effectiveness.

Cologuard is a standalone diagnostic test that involves at-home sample collection and laboratory analysis. It does not directly integrate with real-time endoscopy systems or AI platforms used during endoscopic procedures. However, the ordering and result reporting can be integrated into electronic health record (EHR) systems like EpicCare for streamlined physician workflows and patient management. The test's role is complementary to colonoscopy, serving as a screening method that, if positive, triggers the need for an endoscopic procedure.

Details

Category Gastroenterology AI, Lab & Diagnostics, Oncology AI
Pricing Most insured patients pay $0
  • List price of Cologuard is $649, but most insured patients pay $0; Medicare Part B covers Cologuard Plus with no copay or deductible for eligible members aged 45-85; Medicaid coverage is available in a growing number of state programs, with no payment expected unless the plan requires a copay; The Affordable Care Act may cover Cologuard Plus for eligible out-of-network patients aged 45-75 without a copay or deductible
DeploymentCloud-based (laboratory analysis)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Cleared AI-estimated

Cologuard received FDA premarket approval in August 2014. Cologuard Plus received FDA approval in October 2024 for adults ages 45 and older who are at average risk for colorectal cancer.
Integrations
EHR Not specified
Specialties Gastroenterology, Laboratory Medicine, Oncology

What the Web Says

Cologuard and Cologuard Plus are non-invasive, at-home stool DNA tests for colorectal cancer screening in average-risk individuals aged 45 and older. While praised for convenience, reviews from physicians and users are mixed, with concerns about accuracy, particularly regarding precancerous polyps, and a notable rate of false positives. The newer Cologuard Plus offers improved sensitivity and specificity compared to the original.

Overall: Mixed

Strengths

  • Convenient at-home sample collection with no bowel prep or sedation required.
  • Non-invasive alternative to colonoscopy.
  • FDA-approved for average-risk individuals 45 and older.
  • Cologuard Plus has improved sensitivity (95%) and specificity (94%) for detecting colorectal cancer compared to the original Cologuard.
  • Can be a good option for individuals who are unwilling or unable to undergo a colonoscopy.
  • Detects more precancerous growths than the fecal immunochemical test (FIT).

Limitations

  • Lower accuracy for detecting precancerous polyps compared to colonoscopy.
  • Significant false positive rates can lead to unnecessary anxiety and follow-up colonoscopies.
  • False negatives are possible, potentially missing existing cancers or precancerous lesions.
  • Not recommended for higher-risk individuals with a history of colon cancer, polyps, or inflammatory bowel diseases.
  • A positive result often reclassifies a subsequent colonoscopy as diagnostic, which may lead to different insurance coverage and out-of-pocket costs.
  • Some users report persistent and unwanted communications (texts, calls, emails) from the company.

Based on reviews from: Tryon Medical Partners, Cologuard.com, Reddit, Everyday Health, Gastroenterology Consultants of San Antonio, Becker's ASC, Northeast Tarrant Gastroenterology, Trustpilot, Facebook, YouTube, Woodside Internal Medicine

Last updated: 2026-08-25

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Press & Coverage

Exact Sciences
FDA Approves Exact Sciences' Cologuard Plusu2122 Test, Setting A New Benchmark in Non-Invasive Colorectal Cancer Screening
The FDA approved Exact Sciences' Cologuard Plus test in October 2024 for adults aged 45 and older at average risk for colorectal cancer, based on results from the pivotal BLUE-C study. The test demonstrates 95% overall cancer sensitivity and 43% sensitivity for advanced precancerous lesions at 94% specificity.
2024-10
OncLive
FDA Approves Cologuard Plus for Adults at Average Risk for CRC | OncLive
Cologuard Plus, a next-generation multitarget stool DNA test, received FDA approval for colorectal cancer screening in average-risk adults 45 and older. The BLUE-C trial showed 93.9% overall CRC sensitivity and 43.4% sensitivity for advanced precancerous lesions.
2024-10
Clinical Trials Arena
The New England Journal of Medicine Publishes Cologuard Plusu2122 Test Results from Pivotal BLUE-C Study - Clinical Trials Management
Results from the pivotal BLUE-C study for Cologuard Plus were published in The New England Journal of Medicine in March 2024, detailing its performance characteristics for colorectal cancer and its significant outperformance of the fecal immunochemical test (FIT). The study demonstrated 94% sensitivity for CRC at 91% specificity.
2024-03
Nasdaq
Exact Sciences Launches the Cologuard Plusu2122 Test, Transforming Colorectal Cancer Screening | Nasdaq
Exact Sciences launched Cologuard Plus in March 2025, touting it as the most accurate noninvasive colorectal cancer screening test to date, with 95% sensitivity for CRC detection at 94% specificity. The launch follows FDA approval and Medicare coverage, aiming to reduce false positives by 40% compared to the original Cologuard.
2025-03
Exact Sciences
New Study in Journal of the National Cancer Institute Finds Cologuard Plus - Exact Sciences
A study published in the Journal of the National Cancer Institute in October 2025 found that Cologuard Plus provides the most life-years gained with the fewest colonoscopies among noninvasive screening options. The modeling study highlighted Cologuard Plus as an efficient screening strategy for adults aged 45 to 75.
2025-10
Business Insider
New Colon Cancer Tests: Blood Test and High-Tech Stool Test - Business Insider
A May 2026 article discusses new stool tests like Cologuard Plus, which improves upon previous versions by looking for DNA shed from tumors and cell-free DNA, making it more accurate and sensitive for cancer and pre-cancerous polyps. These tests are more sensitive than standard FIT tests.
2026-05
Forbes
Millions Are Overdue For Colon Cancer Screening - Forbes
A February 2026 Forbes article highlights that millions are overdue for colon cancer screening and discusses Cologuard Plus data, showing it detected 94% of colorectal cancers and many advanced precancerous lesions in a 2024 study. High specificity helps reduce unnecessary follow-up colonoscopies.
2026-02
Healio
New colorectal cancer screening strategies must advance the standard of care
A January 2025 article emphasizes that new colorectal cancer screening strategies, including Cologuard Plus, must advance the standard of care. Modeling analyses suggest Cologuard Plus is a highly efficient non-invasive screening option due to its high sensitivity and specificity for both cancer and precancer.
2025-01

Videos

Product demos, reviews, and walkthroughs for Cologuard / Cologuard Plus.

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Frequently Asked Questions

Cologuard Plus is an enhanced version of the original Cologuard, designed to improve colorectal cancer screening. It incorporates new biomarkers and an updated algorithm to increase sensitivity and specificity, aiming to reduce false positives and negatives. These advancements provide gastroenterologists with a more accurate non-invasive screening tool for their patients.
Patient compliance with Cologuard generally ranges, but studies have shown it to be a valuable option for individuals unwilling or unable to undergo colonoscopy. To improve compliance, physicians can emphasize the non-invasive nature and convenience of the test, provide clear instructions, and offer reminders. Integrating it into routine preventative care discussions can also boost adherence.
While effective, Cologuard and Cologuard Plus have limitations. They are screening tests, not diagnostic, meaning positive results require a follow-up colonoscopy. They may miss some advanced adenomas and early-stage cancers, and are not recommended for individuals with a history of colorectal cancer, certain polyps, or inflammatory bowel disease.
The cost of Cologuard is generally lower than a colonoscopy, especially when considering facility fees and anesthesia. Most major insurance providers, including Medicare, cover Cologuard as a recommended colorectal cancer screening method. Patients should verify their specific coverage to understand any out-of-pocket expenses.
Cologuard or Cologuard Plus is a preferred alternative for average-risk individuals who are unwilling or unable to undergo a colonoscopy. This includes patients with contraindications to colonoscopy, those who decline invasive procedures, or those for whom sedation poses a significant risk. It offers a convenient and effective screening option in these cases.
A positive Cologuard or Cologuard Plus result necessitates a diagnostic colonoscopy. This is crucial to identify the source of the positive result, which could be a polyp, cancer, or other gastrointestinal conditions. The colonoscopy allows for direct visualization, biopsy, and removal of any abnormalities.
No specific dietary or medication restrictions are required before taking the Cologuard or Cologuard Plus test. Patients can maintain their normal diet and medication regimen, which contributes to the test's convenience and ease of use. This lack of preparation is a significant advantage over other screening methods.

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Suggest an Edit → | Last Verified: 2026-08-23 | First Added: 2026-08-23

Investors who backed Cologuard / Cologuard Plus

Funded through the company that built this tool.

Mayo Clinic Ventures
Corporate VC T3
Rochester, United States
$250k-$1M
Mayo Clinic Ventures is the commercialization and venture arm of Mayo Clinic, investing in companies that align with the institution’s clinical and…
AI/ML in Healthcare Biotech
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