FDA Warns Exact Sciences that CRC Assay Requires Premarket Approval | GenomeWeb
NEW YORK (GenomeWeb News) - Exact Sciences said yesterday that it has received a warning letter from the US Food and Drug Administration notifying the company that its colorectal cancer screening assay will require premarket approval.
In the letter, the FDA's Office of In Vitro Diagnostics Device Evaluation and Safety said it believes the company’s DNA-based PreGen-Plus assay is a medical device and therefore requires premarket approval or clearance.

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