title: Plasma Septin9 versus fecal immunochemical testing for colorectal cancer screening: a prospective multicenter study.
abstract: BACKGROUND
  Screening improves outcomes related to colorectal cancer (CRC); however, suboptimal participation for available screening tests limits the full benefits of screening. Non-invasive screening using a blood based assay may potentially help reach the unscreened population.
  
  
  OBJECTIVE
  To compare the performance of a new Septin9 DNA methylation based blood test with a fecal immunochemical test (FIT) for CRC screening.
  
  
  METHODS
  In this trial, fecal and blood samples were obtained from enrolled patients. To compare test sensitivity for CRC, patients with screening identified colorectal cancer (n = 102) were enrolled and provided samples prior to surgery. To compare test specificity patients were enrolled prospectively (n = 199) and provided samples prior to bowel preparation for screening colonoscopy.
  
  
  METHODS
  Plasma and fecal samples were analyzed using the Epi proColon and OC Fit-Check tests respectively.
  
  
  RESULTS
  For all samples, sensitivity for CRC detection was 73.3% (95% CI 63.9-80.9%) and 68.0% (95% CI 58.2-76.5%) for Septin9 and FIT, respectively. Specificity of the Epi proColon test was 81.5% (95% CI 75.5-86.3%) compared with 97.4% (95% CI 94.1-98.9%) for FIT. For paired samples, the sensitivity of the Epi proColon test (72.2% -95% CI 62.5-80.1%) was shown to be statistically non-inferior to FIT (68.0%-95% CI 58.2-76.5%). When test results for Epi proColon and FIT were combined, CRC detection was 88.7% at a specificity of 78.8%.
  
  
  CONCLUSIONS
  At a sensitivity of 72%, the Epi proColon test is non- inferior to FIT for CRC detection, although at a lower specificity. With negative predictive values of 99.8%, both methods are identical in confirming the absence of CRC.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01580540.
authors.affiliation: Gastroenterology Division, Eastern VA Medical School, Norfolk, Virginia, United States of America.
authors.forename: David A
authors.initials: DA
authors.lastname: Johnson
authors.affiliation: Rockford Gastroenterology Associates, Ltd., Rockford, Illinois, United States of America.
authors.forename: Robert L
authors.initials: RL
authors.lastname: Barclay
authors.affiliation: Digestive Health Specialists, Tacoma, Washington, United States of America.
authors.forename: Klaus
authors.initials: K
authors.lastname: Mergener
authors.affiliation: Epigenomics AG, Berlin Germany.
authors.forename: Gunter
authors.initials: G
authors.lastname: Weiss
authors.affiliation: Epigenomics AG, Berlin Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: König
authors.affiliation: Epigenomics AG, Berlin Germany.
authors.forename: Jürgen
authors.initials: J
authors.lastname: Beck
authors.affiliation: Molecular Pathology Laboratory Network, Inc., Maryville, Tennessee, United States of America.
authors.forename: Nicholas T
authors.initials: NT
authors.lastname: Potter
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D003113:Colonoscopy; D015179:Colorectal Neoplasms / Q000175:diagnosis* / Q000473:pathology; D055088:Early Detection of Cancer / Q000379:methods / Q000592:standards; D005260:Female; D006801:Humans; D008297:Male; D008403:Mass Screening / Q000379:methods / Q000592:standards; D008875:Middle Aged; D009367:Neoplasm Staging; D009780:Occult Blood; D011446:Prospective Studies; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D058112:Septins / Q000235:genetics*
chemical_list: C474315:SEPTIN9 protein, human; D058112:Septins