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BioWorld - Monday, December 29, 2025
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Home » FDA greenlights Exact Sciences’ Cologuard Plus
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FDA greenlights Exact Sciences’ Cologuard Plus

Oct. 4, 2024
By Annette Boyle
Exact Sciences Corp.’s Cologuard Plus received U.S. FDA pre-market approval as a non-invasive colorectal cancer home screening test. The next-generation, stool-based assay, developed in conjunction with the Mayo Clinic, reduces false positives by 30% compared to the original Cologuard test without diminishing its sensitivity for cancer or advanced adenomas.
BioWorld MedTech Regulatory Cancer Oncology Diagnostics U.S.

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