Evaluation of the Multi-Cancer Early Detection (MCED) value of YiDiXie™-HS and YiDiXie™-SS

Background Cancer is a serious threat to the whole of humanity. The Multi-Cancer Early Detection (MCED) test is expected to solve the problem of “Universal cancer screening”. The purpose of this study is to evaluate the MCED value of two MCED tests, YiDiXie™-HS and YiDiXie™-SS, in multiple cancer types. Patients and methods 11094 subjects were finally included in this study (the malignant tumor group, n = 4405; the normal control group, n = 6689). The malignant tumor group included all major solid and hematological malignant tumor types. The sensitivity and specificity of YiDiXie™-HS and YiDiXie™-SS were evaluated, respectively. Results The overall sensitivity of YiDiXie™-HS for different cancer types and stages was 90.1% (89.2% - 90.9%; 3971/4405), and its specificity was 89.7% (89.0% - 90.4%; 6002/6689). Its sensitivity increases with clinical stage: stage I, 85.6% (83.9% - 87.1%); stage II, 91.4% (89.6% - 93.0%); stage III, 93.9% (92.0% - 95.4%); and stage IV, 98.4% (96.9% - 99.2%). The overall sensitivity of YiDiXie™-SS for different cancer types and stages was 99.1% (98.8% - 99.3%; 4365/4405), and its specificity was 65.2% (64.0% - 66.3%; 4358/6689). Its sensitivity was basically comparable in each clinical stage: stage I, 98.6% (98.0% - 99.1%); stage II, 99.5% (98.9% - 99.8%); stage III, 99.5% (98.6% - 99.8%); stage IV, 99.8% (98.9% - 100.0%). Conclusion YiDiXie™-HS has a high sensitivity in all clinical stages of all cancer types. YiDiXie™-SS has an extremely high sensitivity in all clinical stages of all cancer types. YiDiXie™-HS and YiDiXie™-SS can replace existing cancer screening tests and are expected to solve the world problem of “Universal cancer screening”. Clinical trial number ChiCTR2200066840.