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

Abstract

BackgroundCancer 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 screening performance of two MCED tests, YiDiXie™-HS and YiDiXie™-SS, in multiple cancer types.Patients and methods11094 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 solid and hematological malignant tumor types covered in “China cancer registry annual report” by the National Cancer Center of China. The sensitivity and specificity of YiDiXie™-HS and YiDiXie™-SS were evaluated, respectively.ResultsThe 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%).ConclusionYiDiXie™-HS has a high sensitivity in all clinical stages of all cancer types and can be a powerful complement to existing cancer screening tests. YiDiXie™-SS has an extremely high sensitivity in all clinical stages of all cancer types and is expected to solve the world problem of “Universal cancer screening”.Clinical trial numberChiCTR2200066840.

Evaluation of the diagnostic value of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D in prostate cancer

“…Subjects who were not qualified in the serum sample quality test prior to the “YiDiXie ™ test” were excluded from the study. For further information on enrollment and exclusion, please see our prior work 13 .…”

“…Participants who had ambiguous pathologic results were excluded from the study. Some of these prostate cancer samples were used in our prior work 13 .…”

“…Perform the "YiDiXie ™ test" according to the instructions of the "YiDiXie ™ all-cancer detection kit". Refer to our prior work for detailed procedures 13 .…”

“…Based on the detection of miRNAs in serum, Shenzhen KeRuiDa Health Technology Co., Ltd. has developed "YiDiXie ™ all-cancer test" (hereinafter referred to as the "YiDiXie™ test") 13 . With only 200 milliliters of whole blood or 100 milliliters of serum, the test can detect multiple cancer types, enabling detection of cancer at home 13 . The "YiDiXie™ test" consists of three independent tests: YiDiXie ™ -HS, YiDiXie™-SS and YiDiXie™-D 13 .…”

“…With only 200 milliliters of whole blood or 100 milliliters of serum, the test can detect multiple cancer types, enabling detection of cancer at home 13 . The "YiDiXie™ test" consists of three independent tests: YiDiXie ™ -HS, YiDiXie™-SS and YiDiXie™-D 13 .…”