Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer (DeeP-C Study). In this pivotal study of multi-target stool DNA (mt-sDNA) vs fecal immunochemical test (FIT), 9989 evaluable and asymptomatic participants with average colorectal cancer (CRC) risk aged 50-84 years provided a stool sample and underwent colonoscopy with mt-sDNA and FITa tests performed on each sample.1 The mt-sDNA test demonstrated significantly greater sensitivity vs FIT for CRC (92.3% vs 73.8%, respectively; P=0.002) and for advanced precancerous lesions (42.4% vs 23.8%, respectively; P<0.001). The overall specificity of mt-sDNA was 87% (vs 95% for FITa) among average risk individuals with nonadvanced or negative findings on colonoscopy and 90% in clean colonoscopy.1 Extrapolation of results from the pivotal study to a hypothetical population of 10,000 persons at average risk for CRC showed that of 1611 individuals (16.1%) who would have a positive mt-sDNA result, only 3.7% would have CRC detected by colonoscopy.
DeeP-C Informational Download
Additional information on the mt-sDNA pivotal study, DeeP-C
Greater sensitivity for CRC1
mt-sDNA: 92.3%
FITa: 73.8%
Greater sensitivity for precancerous lesions1
mt-sDNA: 42.4%
FITa: 23.8%
mt-sDNA PIVOTAL STUDY DESIGN1
mt-sDNA PROVIDED GREATER SENSITIVITY VS FITa ACROSS CRC STAGES AND HIGHER-RISK PRECANCEROUS LESIONS1
- mt-sDNA demonstrated superior sensitivity when compared to a commercially available fecal immunochemical test (FITa) for detecting CRC and advanced adenomas1
- The sensitivity of mt-sDNA for CRC of any stage was 92% (positive results in 60 of 65 cancer cases) versus 74% for FITa (positive results in 48 of 65 cancer cases)1
- mt-sDNA can detect proximal colon cancers with 90% sensitivity (vs 67% for FIT)1,3
SPECIFICITY OF mt-sDNA VS FIT1,a
- The overall specificity of mt-sDNA was 87% (vs 95% for FITa) among average risk individuals with nonadvanced or negative findings on colonoscopy and 90% in clean colonoscopy1
- Of 9167 patients with nonadvanced adenomas, nonneoplastic findings, and negative results on colonoscopy, 1231 (13.4%) tested falsely positive with mt-sDNA1
- Of 4457 patients with totally negative results on colonoscopy, 455 (10.2%) tested falsely positive with mt-sDNA1
- The overall specificity of mt-sDNA was 90% (vs 96.4% in for FITa) among average risk individuals with negative findings on colonoscopy1
- mt-sDNA specificity was 94% among participants younger than 65 years of age and 87% among those 65 years of age or older (P<0.001)1
- The Act Now study evaluated the specificity of mt-sDNA in individuals aged 45-49 years4
EXTRAPOLATION OF STUDY RESULTS TO HYPOTHETICAL POPULATION AT AVERAGE RISK OF CRC1,a,g
- An extrapolation of the pivotal study results to a hypothetical reference population of 10,000 participants at average risk for CRC undergoing screening with mt-sDNA or FIT was conducted
- 83.9% of patients would have screened negative using mt-sDNA and 16.1% would have screened positive1
- Of the negative patients, 99.94% would have accurately screened negative for CRC, leaving 0.06% (or 5 patients out of 10,000) that would have had a CRC missed1
- Of the positive patients, only 3.7% would have been diagnosed with CRC, 19.9% would have had advanced precancerous lesions, 30.9% would have had nonadvanced adenomas, and 45.4% would have had no findings on diagnostic colonoscopy1
- 93.04% of patients would have screened negative using mt-sDNA and 6.9% would have screened positive1
- Of the negative patients, 99.82% would have accurately screened negative for CRC, leaving 0.18% (or 17 patients out of 10,000) that would have had a CRC missed1
- Of the positive patients, only 6.9% would have been diagnosed with CRC, 25.9% would have had advanced precancerous lesions, 31.6% would have had nonadvanced adenomas, and 35.6% would have had no findings on diagnostic colonoscopy1
Learn more about the full Indications/Contraindications for the mt-sDNA test.
Please see complete prescribing information for Cologuard in the Cologuard Clinician Brochure
References
1 Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014;370(14):1287-1297.
2 Ahlquist DA. Multi-target stool DNA test: a new high bar for noninvasive screening. Dig Dis Sci. 2015;60:623-633.
3 Cologuard Clinician Brochure. Exact Sciences Corporation. Madison, WI.
4 Imperiale TF, Kisiel JB, Itzkowitz SH, et al. Specificity of the multi-target stool DNA test for colorectal cancer screening in average-risk 45-49 year-olds: A cross-sectional study. Cancer Prev Res (Phila). 2021;14(4):489-496.
Footnotes
a OC FIT-CHEK, Polymedco, Inc.
b Done within 90 days of providing informed consent.
c Advanced adenoma defined as: colorectal adenoma or sessile serrated adenoma/polyp ≥1.0 cm in diameter, or adenoma with high grade dysplasia ≥25% villous component, of any size.
d Cologuard sensitivity, per stage of cancer: I: 90% (n=29); II: 100% (n=21); III: 90% (n=10); IV: 75% (n=4).
eStatistic calculated using data from the pivotal study and reported within the Ahlquist review article.
f P value is for the trend
g Protocol specified the detection of CRC and advanced precancerous lesionsc as positive findings and the detection of nonadvanced adenomas as negative findings.
h All patients with positive results on FIT or mt-sDNA should be referred for follow-up colonoscopy.
i Advanced precancerous lesions were defined as: adenoma with carcinoma in situ/high grade dysplasia, any size; adenoma, villous growth pattern (≥25%), any size; adenoma ≥1.0 cm in size; or serrated lesion, ≥1.0 cm in size.
Last updated: 04/17/2023