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Exact Sciences prepares 510(k)

This article was originally published in The Gray Sheet

Executive Summary

Marlborough, Mass.-based test maker expects to file a de novo 510(k) for its Version 2 stool-based DNA technology for colorectal cancer screening in the third quarter of 2009, with potential clearance or approval in the first quarter of 2010, the firm says July 10. Now that FDA has confirmed the clinical performance characteristics and minimum number of cancer samples required to validate Version 2, it will take about six to nine months to complete the multi-center, 5,000-patient clinical study and other technical studies, the firm says
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