FDA approves Cologuard Plus, a next-generation stool DNA test for colorectal cancer screening

Later-Stage HumanFDA-approved for the exact stated cancer/useNot addressed

The FDA approved Cologuard Plus, a next-generation multitarget stool DNA test from Exact Sciences, for colorectal cancer screening in adults ages 45 and older at average risk. The approval was based on the pivotal BLUE-C study (ClinicalTrials.gov NCT04144738; primary publication in the New England Journal of Medicine, DOI 10.1056/NEJMoa2310336, PMID 38477986), one of the largest prospective, head-to-head colorectal cancer screening studies conducted, in which 20,176 participants provided a stool sample tested with both Cologuard Plus and a fecal immunochemical test (FIT). Cologuard Plus demonstrated 95% sensitivity for colorectal cancer and 94% specificity (no findings on colonoscopy), outperforming FIT on several measures including sensitivity for advanced precancerous lesions.

What This Means

In the prospective, 20,176-participant BLUE-C study, Cologuard Plus (a next-generation multitarget stool DNA test) detected colorectal cancer with 95% sensitivity and correctly identified 94% of participants without colorectal cancer or advanced precancerous lesions as negative (specificity), outperforming a fecal immunochemical test (FIT) on several measures -- supporting FDA approval for colorectal cancer screening in average-risk adults 45 and older.

What This Doesn't Mean

Cologuard Plus is a SCREENING test for average-risk adults, not a diagnostic test -- a positive result requires a follow-up colonoscopy to confirm or rule out cancer, and it is not validated for higher-risk populations (e.g. those with inflammatory bowel disease, a personal history of colorectal cancer/advanced polyps, or a hereditary colorectal cancer syndrome).

Why It Matters

Non-invasive, at-home stool-based screening options increase the number of people who get screened at all -- colorectal cancer is highly preventable and treatable when caught early through screening, and a validated, next-generation test with improved sensitivity over its predecessor is a genuine, real-world screening advance, in a topic area (early detection/diagnostics) that had thin coverage on this site until now.

Promise & Proof

Proof — strength of the evidence 5 / 5

Base score from evidence stage: Later-Stage Human.
FDA-approved for the exact stated cancer/use.

Promise — potential significance if later evidence holds up 3 / 5

Baseline — a validly-evidenced story starts here; every further point below is an explicit, checkable reason.
The record includes substantive editorial reasoning about why this discovery matters.
A distinct follow-on/confirmatory study or trial is already cited as a secondary source — the field is already building on this finding.

These two ratings are automatically computed from this story's own structured evidence fields and are shown separately on purpose — they are never combined into one score. They describe this record, not a medical recommendation: they do not establish medical certainty, do not substitute for reading the cited sources, and are recalculated whenever the underlying evidence changes.

Population / Applicability

Studied in: Average-risk adults ages 45 and older undergoing colorectal cancer screening, who provided a stool sample tested with both Cologuard Plus and a fecal immunochemical test (FIT), in the prospective, multicenter BLUE-C study. (Adults)

Approved specifically for adults 45 and older at AVERAGE risk of colorectal cancer -- not a substitute for colonoscopy in higher-risk individuals, and a positive Cologuard Plus result must be followed by a diagnostic colonoscopy, not treated as a diagnosis on its own.

Full evidence details

Study design: Other / not applicable
Sample size: 20176

Funding & Conflicts

Sponsor/developer: Exact Sciences Corporation (test manufacturer) -- not independently confirmed against a primary corporate-disclosure document.

Regulatory status by jurisdiction

United States (FDA)

Status: FDA-approved for the exact stated cancer/use
Indication: Colorectal cancer screening in adults ages 45 and older at average risk of colorectal cancer.
Decision date: 2024-10-04
Source: Regulator record (opens in a new tab)

Guideline positions

Guideline

Position: Not addressed
Last verified: 2026-08-13

Primary evidence supporting this story

Next-Generation Multitarget Stool DNA Test for Colorectal Cancer Screening (New England Journal of Medicine) (opens in a new tab) (Peer-reviewed paper) [Peer-reviewed] 10.1056/NEJMoa2310336 Load-bearing source DOI 10.1056/NEJMoa2310336, PMID 38477986
Next-Generation Multitarget Stool DNA Test for Colorectal Cancer Screening (New England Journal of Medicine). DOI 10.1056/NEJMoa2310336, PMID 38477986.

Additional context

BLUE-C trial registry (opens in a new tab) (Clinical-trial registry) NCT04144738 NCT04144738
BLUE-C trial registry. NCT04144738.

Why Should I Trust This?

1 source at Tier 2 — Peer-reviewed primary research, trial registries, regulatory documents, official conference abstracts
Last reviewed: 2026-08-13

This panel summarizes real, checkable facts about this record's own sources and review status — it is not a trust score, and reading it is not a substitute for reading the cited sources yourself.

Discovery Timeline

Every recorded change to this record's content or publication status, in order.

2026-08-13 Status change — Status changed from "Legacy / Unverified" to "In editorial review".
2026-08-13 Status change — Status changed from "In editorial review" to "Verified".

Last reviewed 2026-08-13