Abbott's Cologuard Plus® receives CE Mark for colorectal cancer screening in Europe
Abbott's Cologuard Plus received CE Mark under the EU's IVDR, clearing the path to launch the noninvasive stool-based colorectal cancer screening test in select European markets. In the pivotal BLUE-C study of more than 20,000 participants, the test showed 95% sensitivity for colorectal cancer at 94% specificity, with up to a 40% reduction in false positives versus the original Cologuard.
Key figures
- Drug Name
- Cologuard Plus
- Specificity
- 94%
- Crc sensitivity
- 95%
- Blue c participants
- more than 20,000
- Prior test screenings
- more than 23 million
- False positive reduction
- up to 40% vs original Cologuard
- Advanced precancer sensitivity
- 43%
- High grade dysplasia sensitivity
- 74%
AI analysis
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