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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceEpi proColon
Classification Namesystem, colorectal neoplasia, dna methylation and hemoglobin detection
Generic Namesystem, colorectal neoplasia, dna methylation and hemoglobin detection
Applicant
EPIGENOMICS AG
geneststr.5
berlin 
PMA NumberP130001
Date Received01/03/2013
Decision Date04/12/2016
Product Code
PHP[ Registered Establishments with PHP ]
Docket Number 16M-1168
Notice Date 05/20/2016
Advisory Committee Pathology
Clinical Trials NCT00855348
NCT01580540
Expedited Review Granted? Yes
Combination Product No
Approval Order Statement 
The Epi proColon test is a qualitative in vitro diagnostic test for the detection of methylated Septin 9 DNA in EDTA plasma derived from patient whole blood specimens. Methylation of the target DNA sequence in the promoter region of the SEPT9_v2 transcript has been associated with the occurrence of colorectal cancer (CRC). The test uses a real-time polymerase chain reaction (PCR) with a fluorescent hydrolysis probe for the methylation specific detection of the Septin 9 DNA target. The Epi proColon test is indicated to screen adults of either sex, 50 years or older, defined as average risk for CRC, who have been offered and have a history of not completing CRC screening. Tests that are available and recommended in the USPSTF 2008 CRC screening guidelines should be offered and declined prior to offering the Epi proColon test. Patients with a positive Epi proColon test result should be referred for diagnostic colonoscopy. The Epi proColon test results should be used in combination with physician's assessment and individual risk factors in guiding patient management.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 
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