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

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. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial ChiCTR2200066840 ### Funding Statement This work was supported by Shenzhen High-level Hospital Construction Fund, Clinical Research Project of Peking University Shenzhen Hospital (LCYJ2020002, LCYJ2020015, LCYJ2020020, LCYJ2017001). ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Ethics committee of Peking University Shenzhen Hospital gave ethical approval for this work. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are contained in the manuscript.