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Laboratory Corporation of America’s ColoSure

Laboratory Corporation of America has launched ColoSure, a stool-based testing service for colorectal cancer screening. The test, which uses OncoMethylome’s reagents, is included in the American Cancer Society’s colorectal cancer screening guidelines.
ColoSure is a PCR test that detects methylation of the vimentin DNA marker and determines the presence of colorectal cancer in patients who are traditionally non-compliant to colorectal screening.
OncoMethylome said it earns revenue for supplying LabCorp with the reagents for its test and qualifies for milestones tied to commercial uptake of ColoSure.
Although LabCorp has now launched its own stool-based colorectal cancer screening test, until recently, the company was entangled in a messy regulatory issue surrounding the development of a similar product under a collaboration with Exact Sciences.
In November, the US Food and Drug Administration issued Exact a letter warning that its homebrew stool-based colorectal cancer assay, called PreGen Plus, which the company claimed was developed by LabCorp, was in fact developed by Exact, and needed premarket approval. 

Exact Sciences announced last week plans to submit an application to the FDA for 510(k) clearance of the test by the third quarter of 2009.

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