TITLE

Exact gets warning for cancer test outside 'home brew' rules

PUB. DATE
November 2007
SOURCE
Medical Technology & Devices Week;11/19/2007, Vol. 5 Issue 46, p3
SOURCE TYPE
Periodical
DOC. TYPE
Article
ABSTRACT
The article focuses on the warning letter sent by the U.S. Food and Drug Administration on October 11, 2007 to warn Exact Sciences about its PreGen Plus assay. ProGen Plus is designed for colorectal cancer screening. The letter said that the assay was used by LabCorp in both its main facility and in its plant in Burlington, North Carolina. The use of PreGen served as the red flag that sparked the agency's interest. The agency cited Exact for misbranding the adulteration.
ACCESSION #
27566657

 

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