Cologuard
A home stool test done every three years that looks for cancer DNA and hidden blood; a positive result means you need a colonoscopy.
Overview
Cologuard (Exact Sciences) was approved by the FDA on 11 August 2014 (PMA P130017) for average-risk adults, the first stool DNA screening test. In the pivotal DeeP-C study (NEJM 2014, 9,989 participants) sensitivity for colorectal cancer was 92.3% versus 73.8% for FIT, sensitivity for advanced precancerous lesions 42.4% versus 23.8%, and specificity 86.6% versus 94.9%. It is a USPSTF-endorsed option at a three-year interval, covered by Medicare, and by 2024 more than 16 million tests had been performed. Its weakness is the false-positive rate, which sends about one in eight negative-for-cancer people to colonoscopy, and its limited detection of polyps compared with colonoscopy.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2014 | Colorectal cancer screening in average-risk adults aged 50 and older (later 45 and older) |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Notes
top- What a result means: negative means repeat in three years; positive means a diagnostic colonoscopy, and most positives turn out not to be cancer.
Latest papers
topQuery for this drug: (TITLE:"Cologuard" OR ABSTRACT:"Cologuard") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Cologuard, not a curated reading list.
Pages like this
not linked directly; found by shared links- ProductCancerguard
Shares Exact Sciences (Abbott), Shield, Positive predictive value (PPV), Screening and the tag test.
- ProductSimpleScreen CRC
Shares Cologuard Plus, Shield, Screening, Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood) and the tag test.
- ProductOncodetect
Shares Exact Sciences (Abbott), Colorectal cancer and the tag test.
- ProductGuardant Reveal
Shares DNA methylation profiling, Colorectal cancer and the tag test.
- ProductMI Cancer Seek
Shares Colorectal cancer and the tag test.
- ProductTempus xT CDx
Shares Colorectal cancer and the tag test.
- ProductVENTANA MMR RxDx Panel
Shares Colorectal cancer and the tag test.
- Producttherascreen companion diagnostic kits (KRAS, EGFR, PIK3CA, FGFR, BRAF)
Shares Colorectal cancer and the tag test.