Table 2.
Sensitivity and specificity of the plasma-based mSEPT9 test to detect CRC in LS using the Epi proColon 2.0 CE assay with the ‘1/1 algorithm’
| Group | Presurgical CRC cases (case group 1) |
2 months’ prediagnosis CRC cases (case group 2) | Postsurgical metastatic CRC cases (case group 3) |
Cancer-free controls |
| All cases | 20 | 5 | 13 | 31 |
| Mean age (±SD) | 49.3 (±14.1) | 43.2 (±5.3) | 48.0 (±12.3) | 50.45 (±17.8) |
| Years* | P=0.80 | P=0.062 | P=0.65 | Reference |
| Gene mutated | ||||
| MLH1 | 3 (15.0%) | 1 | 5 (38.5%) | 8 (25.8%) |
| MSH2 | 6 (30.0%) | 3 | 6 (46.1%) | 7 (22.6%) |
| MSH6 | 7 (35.0%) | 1 | 1 (7.7%) | 6 (19.4%) |
| PMS2 | 4 (20.0%) | 0 | 1 (7.7%) | 10 (32.3%) |
| Positive test† | 13/19 | 3/5 | 12/13 | 0/31 |
| Stage I | 4/8 | 1/2 | NA | |
| Stage II | 3/3 | 0/0 | NA | |
| Stage III | 4/6 | 1/2 | NA | |
| Stage IV | 3/3 | 0/0 | 12/13 | |
| Unknown | 0/0 | 1/1 | NA | |
| Sensitivity (95% CI)‡ | 0.70 (0.48 to 0.88) | 0.60 (0.15 to 0.95) | 0.92 (0.64 to 1.00) | NA |
| Specificity (95% CI) | NA | NA | NA | 1.00 (0.89 to 1.00) |
The number of samples for which a valid test result was obtained for the 1 mL plasma sample is included.
*The mean age (±SD) is shown at the time of CRC diagnosis (case groups) or the blood draw (cancer-free control group). The control group showed no significant difference in age from any of the case groups.
†The proportion of positive test results to number of cases with valid test results is shown for each CRC case group, pooled and stratified by stage, and for the cancer-free controls.
‡Sensitivity is provided for all cases within each CRC case group combined by gene mutated and disease stage.
CRC, colorectal cancer; LS, Lynch syndrome; NA, not applicable.