Cologuard®

What Cologuard® does

Cologuard® is a commercial brand and product line of Exact Sciences Corporation (NASDAQ: EXAS) that develops and markets FDA-approved, noninvasive, at-home colorectal cancer screening tests for adults aged 45 and older at average risk. The core technology is a multi-target stool DNA (mt-sDNA) assay that detects both abnormal DNA markers and hemoglobin in a stool sample collected by the patient at home, eliminating the need for bowel preparation, sedation, or time off work associated with colonoscopy. The portfolio comprises the original Cologuard® test (FDA Pre-Market Approval, August 2014), which screens for 10 DNA markers plus blood with 92% overall colon cancer detection, and Cologuard Plus™ (FDA-approved 2024), a next-generation test using five optimized biomarkers with reported 95% colon cancer sensitivity and 99.98% negative predictive value.

Name

Cologuard®

Legal name

Exact Sciences Corporation

Website

https://cologuard.com

Company type

Private

Founded year

2014

Operating status

Operating

Short description

Cologuard®, an Exact Sciences brand, provides FDA-approved noninvasive at-home colorectal cancer screening for U.S. adults 45+ at average risk. Its multi-target stool DNA technology has been used by over 20 million patients, distributed via telehealth, healthcare providers, and insurance partnerships.

Ownership category

akta.pro rank

Product category

Diagnostic Test Kits

NAICS

Medical Laboratories (621511), Medical and Diagnostic Laboratories (6215), In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071)

akta.pro primary industry

Urinalysis & Routine Screening Diagnostics (HLAHAAAG)

akta.pro secondary industry

Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC)

Keywords

• Colorectal cancer screening
• Stool DNA testing
• At-home diagnostic kits
• Noninvasive cancer detection
• Preventive health screening

Headquarters

HQ city

Madison

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2C

Offering type

Hardware or Manufacturing

Cost components

Operations, Marketing or Sales, Technology or R&D, Personnel, Supply Chain

Revenue model

1. Cologuard/Cologuard Plus Test Kits: Revenue generated from sale of FDA-approved colon cancer screening test kits. Most patients (96%) pay $0 due to insurance coverage including Medicare Part B and Medicaid. Self-pay price for Cologuard Plus is $599. Tests are also eligible for FSA, HSA, and HRA reimbursement.
2. Laboratory Testing Services: Exact Sciences Laboratories processes all Cologuard tests at their CLIA-certified laboratory in Madison, WI. Revenue is generated when valid test results are produced and billed to insurance providers, Medicare, or self-pay patients.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels5 records

Core offering

Cologuard® manufactures and distributes FDA-approved, noninvasive, prescription-based, at-home stool collection test kits for colorectal cancer screening in adults aged 45 and older at average risk. The kits use proprietary multi-target stool DNA (mt-sDNA) technology to detect both abnormal DNA markers and blood in stool samples, and are processed at the company's CLIA-certified laboratory in Madison, Wisconsin, with results returned within 8–10 days.

Product overview

Cologuard® offers a portfolio of two FDA-approved, noninvasive, at-home colon cancer screening tests. The original Cologuard test (launched August 2014) detects 10 DNA markers and hemoglobin in stool samples, finding 92% of colon cancers. The newer Cologuard Plus™ test (next-generation, launched 2024) uses five optimized biomarkers for enhanced performance: 95% colon cancer detection, detection of 43% of advanced precancerous growths and 74% of high-risk lesions, with a 99.98% negative predictive value. Both tests are prescription-based, use a stool sample collection kit shipped to the patient's home, and are analyzed in Exact Sciences Laboratories with results returned within 8-10 days. The portfolio serves adults 45+ at average risk for colorectal cancer.

Differentiator

Problem solved

Functional benefit

Brands

• Cologuard Plus™: Next-generation FDA-approved colon cancer screening test with enhanced detection capabilities (95% colon cancer detection), optimized biomarkers, and reduced false positives compared to the original Cologuard test.

Products and services

• Cologuard® FDA-approved, noninvasive, prescription-based, use-at-home stool collection kit for screening adults 45+ at average risk for colorectal cancer. Detects 10 distinct DNA markers and hemoglobin (blood) in stool, with 92% overall colon cancer detection rate in clinical study. Results available in 8-10 days.
• Cologuard Plus™ Next-generation FDA-approved stool DNA test for colorectal cancer screening in adults 45+ at average risk. Uses five optimized biomarkers (DNA and blood) for improved detection: 95% sensitivity for colon cancer, 43% for advanced precancerous growths, 74% for high-risk lesions, and 99.98% negative predictive value. Covered by Medicare Part B with no copay or deductible.

Quantifiable outcome

• 92% of colon cancers detected overall; 94% of stage I & II colon cancers detected in clinical study of 10,000 participants
• +2 more outcomes

Named customers4 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

One partnership is on record.

• Recuro HealthcoreTechnology or IntegrationRecuro Health provides telehealth services enabling Cologuard ordering online. Patients complete a questionnaire through Recuro's platform and receive prescriptions from licensed telehealth providers, allowing direct-to-consumer online ordering of Cologuard kits. This partnership expands access to screening without requiring in-person healthcare visits.

Scale indicators7 records

Recent moves5 records

Expansion highlights4 records

Emerging players

• GRAIL: GRAIL's Galleri multi-cancer early detection test includes CRC signal detection alongside other cancers. While broader in scope, it competes for the same preventive-screening budget and patient population, particularly with health systems and employer wellness programs.
• Natera: Natera's Signatera and emerging oncology detection products address cancer screening and recurrence monitoring. While primarily focused on MRD, its oncology platform intersects with Cologuard's broader cancer-detection mission and target customer base.
• Universal Diagnostics: Universal Diagnostics is developing blood-based cancer screening tests, including CRC. It represents an emerging competitor in the noninvasive screening space that could overlap with Cologuard's target patient population if commercialized.
• Mainz Biomed: Mainz Biomed is developing ColoAlert, a stool-based molecular CRC screening test. It is a more regional / emerging competitor with similar core technology (stool DNA) targeting the same average-risk screening population as Cologuard.

Direct peers

• Geneoscopy: Geneoscopy's ColoSense is an FDA-approved stool-based RNA screening test for CRC. It directly competes with Cologuard in the same stool-sample, noninvasive CRC screening category and competes for the same provider prescriptions.
• Guardant Health: Guardant Health offers Shield, an FDA-approved blood-based colorectal cancer screening test. It competes directly with Cologuard for noninvasive CRC screening share, particularly with patients who prefer a blood draw over stool collection.
• Freenome: Freenome is developing a blood-based multiomics screening test for early CRC detection. It targets the same average-risk screening population as Cologuard and represents the next generation of noninvasive CRC screening competitors.

Others

• Polymedco: Polymedco manufactures OC-Auto FIT, one of the most widely used fecal immunochemical tests for CRC screening. It is an indirect competitor and adjacent technology provider competing for the same noninvasive CRC screening population through different modalities.

Broad incumbents

• Laboratory Corporation of America (Labcorp): Labcorp is a major clinical laboratory network offering FIT and other CRC screening services. As a broad incumbent, it competes with Cologuard through established health system relationships, complementary screening modalities, and in-office test options.
• Quest Diagnostics: Quest Diagnostics is a national reference laboratory offering FIT testing and other CRC screening diagnostics. It is a broad incumbent in the diagnostic lab space that competes for the same screening volume through different test modalities and health system contracts.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/channel/UCnFQBx65LmJiUr7fuD7h4Cw
• Facebookfacebook.com/Cologuard
• Instagraminstagram.com/cologuard
• Xx.com/cologuard

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Cologuard®