Clinical Utilization

Multi-target stool DNA (mt-sDNA) test utilization for colorectal cancer (CRC) screening has increased rapidly since it was approved in 2014.1 Since its approval, real-world data suggest growing patient and provider interest in the mt-sDNA test as a non-invasive screening modality for average-risk CRC screening.1 Furthermore, real-world data have demonstrated the clinical effectiveness of mt-sDNA in diverse clinical practice.2

In one study, neoplasia was found in 68.0% of patients having colonoscopy after a positive mt-sDNA test, versus 42.3% of patients with colonoscopy only2

Individuals with positive mt-sDNA tests were significantly more likely than colonoscopy-only patients to have CRC2

COLONOSCOPY OUTCOMES FOLLOWING POSITIVE mt-sDNA TEST2

    Colonoscopy post-positive mt-sDNA   Colonoscopy
only 		Fisher exact test P-value  
  Colonoscopy outcomes   (N=240) (N=719)    
   N %  N %  
  Any neoplasia  161 67.1   286  39.8  <0.0001
  <Most advanced finding on colonoscopy          
  Adenocarcinoma/colorectal cancer  4 1.7  2  0.3  <0.0001
  Advanced noncancerous neoplasia  60 25.0 57 7.9
  Non-advanced neoplasia  97 40.4 227 31.6
  Normal exam/nonsignificant findings  79 32.9 433 60.2
  Missing outcome  0   1  

COLONOSCOPY PREPARATION QUALITY AND EXAM COMPLETENESS2

   Colonoscopy following positive mt-sDNA test  Colonoscopy only P-Value
   N(%) N(%)  
Total Number of patients  306 918  
 Preparation quality      0.306
Excellent  72 (27.6%) 261 (32.6%)  
Good  169 (64.8%) 482 (60.3%)  
Fair 20 (7.7%) 57 (7.1%)  
Missing 45 118  
Exam Completeness      1
Complete to the cecum/TI  290 (100%) 868 (100%)  
Missing  16 50  

  • The vast majority (83.3%) of patients with mt-sDNA tests had colonoscopy within 3 months of the positive mt-sDNA2
  •  Individuals with positive mt-sDNA tests (N=306, average age 67.0 yrs; 61.8% female) were significantly more likely than colonoscopy-only patients (N=918, 66.2 yrs; 61.8% female) to have CRC (1.3% vs 0.4%) or advanced non-cancerous neoplasia (27.1% vs 8.2%) (P<0.0001)2
  • Neoplasia was found in 68.0% of patients having colonoscopy after a positive mt-sDNA test, (positive predictive value, PPV, was 68.0%), versus 42.3% of patients with colonoscopy only (P<0.0001)2
  • This regression found that, independent of BMI, smoking, date of colonoscopy and aspirin/NSAID use, mt-sDNA positive status is associated with abnormal colonoscopy findings (OR=2.66, 95% CI: 1.79 – 3.98; P<0.0001)2
  • No significant differences in colonoscopy quality measures were observed between cohorts2
  • This retrospective study examined colonoscopy findings between Jan 2015 and Jun 2019 of patients with positive mt-sDNA results in the NHCR database
  • Average risk patients only. The mt-sDNA positive patients (n=306) were matched by age (±5 years), sex, and CRC risk (average or increased) at a 1:3 ratio to a cohort of 918 unique patients who received a colonoscopy indicated for screening or surveillance with no prior positive mt-sDNA result

UTILIZATION OF CRC SCREENING MODALITIES FROM 2014 TO 20181

Line graph showing rates of screening modality use over time
  • mt-sDNA testing increased significantly from 2014 to 2018 (2481 to 335,455 claims; P<0.001)1
    • Compound annual growth rate was higher for mt-sDNA (166.81%) than for colonoscopy (0.52%), FOBT (-11.75%), and FIT (0.67%)1
  • Colonoscopy (high and low risk codes) accounted for most of the CRC screening tests and remained relatively stable1
  • Findings support growing patient and provider interest in the mt-sDNA test as a non-invasive option for average-risk CRC screening1
  • This study analyzed and compared recent trends in colonoscopy, FS, FOBT, FIT, and mt-sDNA screening for CRC, using Medicare online claims data
  • FS represented <1% of all CRC screening tests over the entire analysis period
Learn more about the full Indications/Contraindications for the mt-sDNA test.   Please see complete prescribing information for Cologuard in the Cologuard Clinician Brochure

Related Topics

CRC: colorectal cancer, mt-sDNA: multi-target stool DNA, FOBT: fecal occult blood test, FIT: fecal  immunochemical test, FS: flexible sigmoidoscopy 

References

1 Limburg PJ, Finney Rutten LJ, Ozbay AB, et al. Recent trends in colorectal cancer screening methods based on Medicare claims data. Curr Med Res Opin. 2021;37(4):605-607.

2 Anderson JC, Robinson CM, Hisey WM, et al. Colorectal neoplasia detection in individuals with positive multitarget stool DNA tests: data from the New Hampshire Colonoscopy Registry. J Clin Gastroenterol. 2022 May-Jun;56(5):419-425.

Footnotes

a Medicare CPT code: G0121 (colorectal cancer screening; colonoscopy on an individual not meeting criteria for high risk).

b Medicare CPT code: G0105 (colorectal cancer screening; colonoscopy on individual at high risk).

Last updated: 04/22/2023