Multitarget 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 noninvasive 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 after a positive mt-sDNA test was more frequently associated with CRC detection than colonoscopy alone2
COLONOSCOPY OUTCOMES FOLLOWING POSITIVE mt-sDNA TEST IN AVERAGE-RISK PATIENTS2,a
| Colonoscopy outcomes in average-risk patients | Colonoscopy post-positive mt-sDNA (N=240) | Colonoscopy only (N=719) | Fisher exact test P value |
|---|---|---|---|
| n (%) | |||
| Any neoplasia | 161 (67.1) | 286 (39.8) | <0.0001 |
| Most advanced finding on colonoscopya | |||
| Adenocarcinoma/CRC | 4 (1.7) | 2 (0.3) | <0.0001 |
| Advanced noncancerous neoplasia | 60 (25) | 57 (7.9) | |
| Nonadvanced neoplasia | 97 (40.4) | 227 (31.6) | |
| Normal exam/nonsignificant findings | 79 (32.9) | 433 (60.2) | |
| Missing outcome | 0 | 1 | |
Table adapted from Anderson, 20222
COLONOSCOPY PREPARATION QUALITY AND EXAM COMPLETENESS IN ALL PATIENTS2,b
| Colonoscopy characteristics | Colonoscopy following positive mt-sDNA test | Colonoscopy only | P value |
|---|---|---|---|
| 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 | |
Table adapted from Anderson, 20222
- 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 years; 61.8% female) were significantly more likely than colonoscopy-only patients (N=918, 66.2 years; 61.8% female) to have CRC (1.3% vs 0.4%) or advanced noncancerous 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 January 2015 and June 2019 of patients with positive mt-sDNA results in the NHCR database2
- 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 result2,c
UTILIZATION OF CRC SCREENING MODALITIES FROM 2014 TO 20181
- 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 noninvasive 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 the Cologuard® test in the Cologuard Clinician Brochure.
FIT: fecal immunochemical test; mt-sDNA: multitarget stool DNA.
Footnotes
- Advanced noncancerous neoplasia includes adenomas or serrated polyps ≥1 cm, all traditional serrated adenomas or sessile serrated polyps with dysplasia, and all polyps with ≥25% villous elements and/or high-grade dysplasia of any size; nonadvanced neoplasia includes tubular adenomas or serrated polyps <1 cm; and normal examinations/nonsignificant findings include examinations with only rectosigmoid hyperplastic polyps <5 mm or nonneoplastic findings.
- Percentages calculated out of nonmissing totals.
- Between January 2011 and June 2019.
- Medicare CPT code: G0121 (colorectal cancer screening; colonoscopy on an individual not meeting criteria for high risk).
- Medicare CPT code: G0105 (colorectal cancer screening; colonoscopy on high-risk individuals), and G0121.
List of definitions
BMI: body mass index; CPT: current procedural terminology; CRC: colorectal cancer; FIT: fecal immunochemical test; FOBT: fecal occult blood test; FS: flexible sigmoidoscopy; mt-sDNA: multitarget stool DNA; NHCR: New Hampshire Colonoscopy Registry; NSAID: nonsteroidal anti-inflammatory drug; OR: odds ratio; PPV: positive predictive value; TI: terminal ileum.
References
- 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.
- 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;56(5):419-425.