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The updated Cologuard, approved in 2024, which keeps the high cancer detection rate while causing fewer false alarms.
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.
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.
1.Cologuard Plus slips into a pocket on its target.
| Region | Year | Indication |
|---|---|---|
| US | 2024 | Colorectal cancer screening in average-risk adults aged 45 and older |
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Query for this drug: (TITLE:"Cologuard Plus" OR ABSTRACT:"Cologuard Plus") 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 Plus, not a curated reading list.
Shares Exact Sciences (Abbott), Shield, Screening, DNA methylation profiling and the tag test.
Shares Exact Sciences (Abbott), Colorectal cancer and the tag test.
Shares Sensitivity and specificity 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.