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A home stool test done every three years that looks for cancer DNA and hidden blood; a positive result means you need a colonoscopy.
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.
Stool sample analysed for methylated NDRG4 and BMP3, mutant KRAS, and faecal haemoglobin, combined by an algorithm into a positive or negative result.
1.Cologuard slips into a pocket on its target.
| Region | Year | Indication |
|---|---|---|
| US | 2014 | Colorectal cancer screening in average-risk adults aged 50 and older (later 45 and older) |
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Query 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.
Shares Exact Sciences (Abbott), Shield, Positive predictive value (PPV), Screening and the tag test.
Shares Cologuard Plus, Shield, Screening, Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood) and the tag test.
Shares Exact Sciences (Abbott), Colorectal cancer and the tag test.
Shares DNA methylation profiling, Colorectal cancer and the tag test.
Shares Colorectal cancer and the tag test.
Shares Colorectal cancer and the tag test.
Shares Colorectal cancer and the tag test.
Shares Colorectal cancer and the tag test.