FDA Grants Approval for Exact Sciences’ Cologuard Plus, an Enhanced At-Home Screening Test

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A decade after its initial FDA approval, Exact Sciences has received the green light for Cologuard Plus, the updated version of its at-home colorectal cancer screening test.

Cologuard Plus incorporates newly identified genetic biomarkers into its multi-target stool DNA test, reducing the rate of false positives by 30%, while maintaining similar sensitivity in detecting tumors and advanced precancerous polyps.

As reported by fiercebiotech, this enhancement is expected to reduce the number of unnecessary follow-up colonoscopies. The test is intended for individuals at average risk of colorectal cancer, including those without a family history or previous diagnosis.

Developed in partnership with the Mayo Clinic, Cologuard Plus has also improved the sample stability, allowing users more time to return the kit to Exact Sciences’ lab.

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