|Classification Name||system, colorectal neoplasia, dna methylation and hemoglobin detection|
|Generic Name||sdna-based colorectal cancer screening test|
|Applicant||EXACT SCIENCES CORPORATION|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change the following: use of software spreadsheet workbook for automated data processing in place of manual calculations of acceptance criteria for quality control (qc) test; revision of the upper specification limit for qc blank positivity for markers btact and act; relocation of the qc laboratories from the first floor to the second floor within the same facility; and relocation of the labeling and dispensing activities into other rooms on the same floor.