A multiplex urinary immunoassay for bladder cancer detection: Analysis of a Japanese cohort

Steve Goodison, Osamu Ogawa, Yoshiyuki Matsui, Takashi Kobayashi, Makito Miyake, Sayuri Ohnishi, Kiyohide Fujimoto, Yunfeng Dai, Yoshiko Shimizu, Kazue Tsukikawa, Hideki Furuya, Charles J. Rosser

Research output: Contribution to journalArticlepeer-review

19 Scopus citations


Background: Bladder cancer (BCa) is among the most commonly diagnosed malignancies worldwide, and due the high rate of post-operative disease recurrence, it is one of the most prevalent in many countries. The development of non-invasive molecular assays that can accurately detect and monitor BCa would be a major advance, benefiting both patients and healthcare systems. We have previously identified a urinary protein biomarker panel that is being developed for application in at-risk patient cohorts. Here, we investigated the potential utility of the multiplex assay in a Japanese cohort. Methods: The Japanese study cohort collected from urology clinics at two institutions was comprised of a total of 288 subjects. The protein biomarker panel (IL8, MMP9, MMP10, ANG, APOE, SDC1, A1AT, PAI1, CA9, VEGFA) was monitored in voided urine samples collected prior to cystoscopy using a custom multiplex ELISA assay. The diagnostic performance of the biomarker panel was assessed using receiver operator curves, predictive modeling and descriptive statistics. Results: Urinary biomarker concentrations were significantly elevated in cases versus controls, and in cases with high-grade and muscle-invasive tumors. The AUC for the 10-biomarker assay was 0.892 (95 % confidence interval 0.850-0.934), with an overall diagnostic sensitivity specificity of 0.85 and 0.81, respectively. A predictive model trained on the larger institutional cohort correctly identified 99 % of the cases from the second institution. Conclusions: Urinary levels of a 10-biomarker panel enabled discrimination of patients with BCa. The multiplex urinary diagnostic assay has the potential to be developed for the non-invasive detection of BCa in at-risk Japanese patients.

Original languageEnglish (US)
Article number287
JournalJournal of Translational Medicine
Issue number1
StatePublished - Oct 7 2016


  • Biomarkers
  • Bladder cancer
  • Multiplex
  • Protein
  • Urine

ASJC Scopus subject areas

  • General Biochemistry, Genetics and Molecular Biology


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