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Exact Sciences Clarifies Colorectal Cancer Test Status, Touts Tech’s Benefits

This article was originally published in The Gray Sheet

Executive Summary

Exact Sciences and licensing partner LabCorp are newly committed to improving appreciation for stool-based DNA testing, confident that their PreGen-Plus colorectal cancer screening assay meets FDA criteria as a "homebrew" exempt from agency oversight

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LabCorp will continue to market Exact Sciences' PreGen-Plus colorectal cancer screening assay pending further word from FDA, which has indicated that the diagnostic may require regulation as a medical device, Exact Sciences says

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