Exact Sciences
Publicly traded manufacturer of non-invasive cancer screening diagnostics, known for the Cologuard test.
Updated Jul 1, 2026
Headquartered in United States
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Overview
About Exact Sciences
Exact Sciences manufactures non-invasive molecular diagnostic tests for cancer screening, including the Cologuard colorectal cancer test, and is publicly traded on the Nasdaq.
Products
- Non-invasive colorectal cancer screening tests
- Molecular diagnostics
Markets Served
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Related
Certifications
ISO 13485
The international quality management system standard specific to medical device manufacturers, referenced by most major regulators.
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CE Mark
The conformity mark required to sell medical devices in the EU/EEA, issued once a device meets EU MDR or IVDR requirements.
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FDA 510(k) / PMA
US market authorization for medical devices via the FDA's 510(k), De Novo, or PMA pathways.
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Related
Regulatory Pathways
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