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Exact Sciences

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Exact Sciences is a molecular diagnostics company focused on early cancer detection. They are best known for Cologuard, a non-invasive colorectal cancer screening test. Exact Sciences develops and markets tests for various cancer types.

Exact Sciences’ in vitro diagnostic tests are regulated by the FDA in the United States. Cologuard received FDA approval through the Premarket Approval (PMA) pathway. The company adheres to FDA 21 CFR Part 820 for quality system regulation.

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