YiDiXie tests aid bladder cancer diagnosis

By Agata Buczak 

Huimei Zhou (Peking University Shenzhen Hospital, Guangdong, China) and colleagues recently published a study in European Journal of Medical Research evaluating three YiDiXie™ serum-based tests for diagnosing urothelial carcinoma (UC). The panels, YiDiXie™‑30, ‑32, and ‑48, detect multiple microRNA (miRNA) biomarkers using fluorescence quantitative polymerase chain reaction (PCR) and were evaluated in 439 participants across malignant (n=292), benign (n=90), postoperative relapse (n=22), and relapse‑free (n=35) cohorts.

Performance was compared between malignant and benign groups and then explored alongside imaging modalities (computed tomography [CT]) and postoperative ultrasound (B‑scan). Across malignant versus benign cohorts, YiDiXie™-48 demonstrated the highest sensitivity (96.2%) but lower specificity (65.6%), while YiDiXie™-30 achieved the highest specificity (92.2%) with moderate sensitivity (74.7%). YiDiXie™-32 balanced performance, with 86.6% sensitivity and 84.4% specificity. Receiver-operating characteristic (ROC) analysis reported area under the curve (AUC) values of 0.834, 0.855, and 0.809 for YiDiXie™-30, -32, and -48, respectively.

Test accuracy remained consistent in patients irrespective of CT status. For CT-positive cases, YiDiXie™-48 reached 95.9% sensitivity, and for CT-negative cases, sensitivity was 96.9%. Combining YiDiXie™ tests with CT improved diagnostic accuracy: YiDiXie™-48 plus CT achieved 99.0% sensitivity, while YiDiXie™-30 plus CT delivered the highest specificity (76.7%). In postoperative monitoring, pairing YiDiXie™ assays with B-ultrasound enabled detection of recurrence, with YiDiXie™-48 plus ultrasound achieving 100% sensitivity for recurrence detection.

The authors highlight constraints of current diagnostics, such as invasiveness, cost, and false results. YiDiXie™ testing requires only 20 μL of serum obtained via finger-prick, allowing self-collection and mailing of samples, potentially widening access and reducing reliance on resource-intensive pathways.

Study limitations include the single-center design and modest sample size. The authors recommend multicenter validation and direct comparisons against standard tests to confirm generalizability and define clinical utility.

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