Exact Sciences’ Cologuard Plus Test Approved by FDA for Colorectal Cancer Screening

The FDA has approved Exact Sciences Corp.’s Cologuard Plus test, a next-generation stool DNA test for colorectal cancer (CRC) screening in adults aged 45 and older. This approval is based on the BLUE-C study, demonstrating superior performance compared to its predecessor, Cologuard, and other fecal immunochemical tests. Cologuard Plus will be available in 2025, supported by ExactNexus technology and anticipated Medicare coverage.

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