# Cologuard Plus

Source: https://onco.cc/drugs/cologuard-plus/  
OnCo record `cologuard-plus` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The updated Cologuard, approved in 2024, which keeps the high cancer detection rate while causing fewer false alarms.

## Summary

Cologuard Plus was approved by the FDA in October 2024 and launched in 2025. In the BLUE-C study (NEJM 2024, more than 20,000 participants) sensitivity for colorectal cancer was 93.9% versus 67.3% for FIT, sensitivity for advanced precancerous lesions was 43.4% versus 23.3%, and specificity for advanced neoplasia was 90.6% versus 94.8%, a roughly 30% reduction in false positives compared with the original Cologuard. The test is used every three years in average-risk adults aged 45 and older. Exact Sciences, now being acquired by Abbott, positions it against blood tests such as Shield, whose sensitivity for precancerous polyps is much lower.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-10
- Tags: test
- Brand: Cologuard Plus
- Modality: Next-generation multitarget stool DNA colorectal cancer screening test
- Mechanism: Redesigned stool test measuring methylated DNA markers (LASS4, LRRC4, PPP2R5C, ZDHHC1) and faecal haemoglobin with a new algorithm, replacing the mutation markers of the original test.
- Approvals: US 2024: Colorectal cancer screening in average-risk adults aged 45 and older

## Notes

- What a result means: the same as Cologuard, with fewer people sent for a colonoscopy they did not need.

## Sources

- BLUE-C (NEJM 2024): https://doi.org/10.1056/NEJMoa2310336
- Exact Sciences: Cologuard Plus: https://www.exactsciences.com/

## Connected records

- drugs: [Cologuard](https://onco.cc/drugs/cologuard/), [Shield](https://onco.cc/drugs/shield/), [SimpleScreen CRC](https://onco.cc/drugs/simplescreen-crc/)
- cancers: [Colorectal cancer](https://onco.cc/cancers/colorectal/)
- technologies: [Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood)](https://onco.cc/technologies/colorectal-screening/), [DNA methylation profiling](https://onco.cc/technologies/methylation-profiling/), [Multitarget stool RNA test (ColoSense)](https://onco.cc/technologies/multitarget-stool-rna-test/)
- companies: [Exact Sciences (Abbott)](https://onco.cc/companies/exact-sciences/)
- terms: [Faecal immunochemical test (FIT)](https://onco.cc/terms/fit-test/), [Screening](https://onco.cc/terms/screening/), [Sensitivity and specificity](https://onco.cc/terms/sensitivity-specificity/)
- trials: [BLUE-C](https://onco.cc/trials/blue-c/)
- targets: [PPP2R5C](https://onco.cc/targets/ppp2r5c/)

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