DeeP-C

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

Pivotal study design infographic

mt-sDNA PROVIDED GREATER SENSITIVITY VS FITa ACROSS CRC STAGES AND HIGHER-RISK PRECANCEROUS LESIONS1

Bar chart displaying FIT vs mt-sDNA sensitivity
  • 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 FIT(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

Dot chart showing specificity of mt-sDNA and FIT
  • 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

Pie chart of mt-sDNA results breakdown
  • 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
Pie chart of FIT results breakdown
  • 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 mt-sDNA in the Cologuard Physician Brochure.

References

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.

Ahlquist DA. Multi-target stool DNA test: a new high bar for noninvasive screening. Dig Dis Sci. 2015;60:623-633.

Cologuard Physician Brochure. Exact Sciences Corporation. Madison, WI.

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 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.

Cologuard sensitivity, per stage of cancer: I: 90% (n=29); II: 100% (n=21); III: 90% (n=10); IV: 75% (n=4).

e Statistic calculated using data from the pivotal study and reported within the Ahlquist review article.

P value is for the trend

Protocol specified the detection of CRC and advanced precancerous lesionsc as positive findings and the detection of nonadvanced adenomas as negative findings.

All patients with positive results on FIT or mt-sDNA should be referred for follow-up colonoscopy.

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: 3/1/2022