COLOGUARD
FDA premarket approval P130017 · decided 2014-08-11
Approval details
- PMA number
- P130017
- Trade name
- COLOGUARD
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Applicant
- Exact Sciences Corporation
- Date received
- 2013-06-07
- Decision date
- 2014-08-11
- Days to decision
- 430 days
- Decision code
- APPR
- Product code
- PHP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Medison, WI
- Statement
- APPROVAL FOR THE COLOGUARD. 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 COLONOSC
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