Colorectal cancer rapid screening test Cologuard Plus®

fecal occult bloodinflammatory bowel diseaseblood

Overview
Cologuard Plus® is an FDA‑approved at-home stool-based screening test for colorectal cancer in average-risk adults aged 45 and older. The assay simultaneously analyzes stool for abnormal DNA markers and fecal blood using five optimized biomarkers, enabling detection of cancer and advanced precancerous lesions without bowel preparation or changes to diet or medication.

Key features

• Indicated for average-risk adults 45+ for colorectal cancer screening
• Detects both abnormal stool DNA and fecal blood
• No dietary or medication changes required; no bowel prep
• Sample collected at home and returned in prepaid shipping box
• FDA‑approved

Performance
Clinical data report approximately 95% sensitivity for colorectal cancer detection overall; in a subgroup aged 45–59, studies reported 100% detection in the study sample. Reported negative predictive values and accuracy for negative results are very high (~99.9% / 99.98%, population dependent). Detection rates for advanced precancerous lesions have been reported around 43% and 74% for high‑risk lesions in the cited study population.

How it works
Colorectal epithelial cells shed into stool. Cologuard Plus® analyzes stool samples for DNA alterations from these cells alongside indicators of blood, using a panel of five biomarkers to identify cancerous and precancerous changes.

Screening workflow

• Request the test via a healthcare provider or telehealth
• Receive the kit at the workplace or home
• Collect a single stool sample following the included instructions
• Return the sample using the prepaid shipping box
• Receive results typically within 8–10 days after the laboratory receives the sample

Comparison (summary table)
Screening test feature | Cologuard Plus | Colonoscopy | FIT (Fecal Immunochemical Test) | FOBT (Fecal Occult Blood Test) | Blood test
Noninvasive | yes | no | yes | yes | yes
No prep required | yes | no | yes | no | yes
Collect sample at home | yes | no | yes | yes | no
Indicated for colorectal cancer detection | yes | yes | yes | no | yes
Indicated for detection of precancer | yes | yes | yes | no | no

Patient considerations
Cologuard Plus® is intended for average‑risk adults 45 years and older and is not indicated for individuals with certain high‑risk conditions (for example, personal or first‑degree family history of colorectal cancer, inflammatory bowel disease, known adenomas, or recent positive screening). Positive noninvasive results require diagnostic colonoscopy for confirmation. Negative results reduce but do not eliminate cancer risk; ongoing screening intervals should be determined with a healthcare provider.

Technical specifications

• Commercial name: Cologuard Plus®
• Intended population: adults 45+ at average risk for colorectal cancer
• Method: stool analysis for abnormal DNA markers and fecal blood; powered by 5 optimized biomarkers
• Regulatory status: FDA‑approved
• Clinical performance: ~95% cancer detection reported; detects a proportion of advanced precancerous lesions (reported 43% advanced precancers; 74% high‑risk lesions)
• Negative predictive characteristics: reported ~99.9% (population dependent)
• Specimen collection: at‑home stool sample; no bowel prep; no dietary/medication changes required
• Sample return: prepaid shipping box
• Turnaround time: ~8–10 days after sample receipt
• Follow-up: positive noninvasive test requires colonoscopy for diagnosis