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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCologuard
Generic NameSystem, colorectal neoplasia, DNA methylation and hemoglobin detection
ApplicantExact Sciences Corporation
441 Charmany Dr.
Medison, WI 53719
PMA NumberP130017
Supplement NumberS017
Date Received05/22/2017
Decision Date11/06/2017
Product Code PHP 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for changes to the Cologuard Hemoglobin Assay Process and Reagents. The device, as modified, will be marketed under the trade name Cologuard and is indicated for use as follows: Cologuard is intended for the qualitative detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool. Cologuard is for use with the Cologuard collection kit and the following instruments: BioTek® Epoch 2 Absorbance Microplate Reader; Applied Biosystems® 7500 Fast Dx Real-Time PCR; Hamilton Microlab® STARlet; and the Exact Sciences System Software with Cologuard Test Definition. This assay is to be performed at Exact Sciences Laboratory, located at 145 E. Badger Rd, Suite 100, Madison, Wisconsin.Cologuard is intended for the qualitative detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool. A positive result may indicate the presence of colorectal cancer (CRC) or advanced adenoma (AA) and should be followed by diagnostic colonoscopy. Cologuard is indicated to screen adults of either sex, 50 years or older, who are at typical average-risk for CRC. Cologuard is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high risk individuals.
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