Validation of a mRNA-based urine test for bladder cancer detection in patients with hematuria

Valenberg, F Johannes P van; Bridge, Julia A.; Mayne, Donna; Beqaj, Safedin; Sexton, Wade J.; Lotan, Yair; Weizer, A.Z.; Jansz, G.K.; Stenzl, Arnulf; Danella, John; Shepard, Barry; Cline, Kevin; Williams, Michael B.; Montgomery, Terri; David, Raffaele; Harris, Robert G.; Klein, Eric; Bradford, Timothy J.; Wolk, Fred; Westenfelder, K.R.; Trainer, Andrew; Richardson, Tim; Witjes, J.A.

doi:10.1016/s1569-9056(17)30183-5

Cited by 9 publications

(8 citation statements)

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“…It is important to highlight the significance of these results in comparison to other urinary biomarkers for bladder cancer 5,19,29–33 . We have confirmed that URO17™ has one of the highest sensitivity and specificity reported in identifying bladder cancer through noninvasive urine samples.…”

Section: Discussionsupporting

confidence: 69%

“…It is important to highlight the significance of these results in comparison to other urinary biomarkers for bladder cancer. 5,19,[29][30][31][32][33] We have confirmed that URO17™ has one of the highest sensitivity and specificity reported in identifying bladder cancer through non- and expands the application of URO17™ to hematuria patients. In the end, combinations of biomarkers may be the key to providing the most effective investigation where the application of URO17™…”

Section: Discussionsupporting

confidence: 68%

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The role of URO17™ biomarker to enhance diagnosis of urothelial cancer in new hematuria patients—First European Data

et al. 2020

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Introduction and objectives Novel biomarker research is vital for the progression of safe and thorough diagnostic medicine. There is now a need to improve the diagnosis of bladder cancer via a noninvasive urine test while balancing the risks of harm from investigational procedures, such as cystoscopy and radiological tests, against the likelihood of malignancy. We evaluate the diagnostic accuracy and sensitivity of Uro17™ urinary biomarker for the detection of urothelial cancer in hematuria patients in a prospective blinded validation study. Uro17™ is an immunobiomarker which binds to the oncoprotein Keratin 17, which is involved in the replication cycle of malignant cells. This study compared cystoscopic and histological investigations against Uro17™ results in patients being investigated for symptoms of urothelial cancer. Materials and methods After receiving both local and national ethics/protocol approval, 71 patients were consented and recruited into the study. All patients were scheduled to undergo cystoscopic investigation, and following recruitment, a urine sample was collected. Urine samples were anonymized and processed as per standard cytology protocols and stained using Uro17™ immunobiomarker. The pathologists assessing the results were blinded to the patient and background history, and the results were compared to the biopsy histology. Results The full cohort of enrolled patients consisted of 71 participants included. There were 55 males and 16 females, with an average age of 70. Thirteen were current smokers, 42 ex‐smokers, and 16 nonsmokers. The malignancies detected included both muscle‐invasive (n = 6) and non‐muscle‐invasive tumors (n = 38), and tumors of all grades and carcinoma in situ. Uro17™ was shown to have an overall sensitivity of 100% and a specificity of 92.6%, with a positive predictive value of 0.957 and negative predictive value of 1. Uro17™ investigation was positive in every case of urothelial malignancy. Conclusions Our current data indicates Uro17™ is a highly sensitive noninvasive bladder cancer urine detection test that can improve the diagnosis of Bladder cancer. This can further improve diagnostic capabilities in primary care, reduce the number of referrals to Urology department, and reduce the number of unnecessary invasive procedures for new patients with a suspected urinary bladder cancer.

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Section: Discussionsupporting

confidence: 69%

Section: Discussionsupporting

confidence: 68%

The role of URO17™ biomarker to enhance diagnosis of urothelial cancer in new hematuria patients—First European Data

et al. 2020

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“…These markers are related to proliferation and survival ( IGF2 ), neuroendocrine stress response and inflammation ( CRH ), cell growth and signal transduction ( ANXA10 ), and epigenetic dysregulation in BCa ( UPK1B ). Recently, the first prospective study was conducted to evaluate the efficiency of the Xpert BC Monitor 64,65. In this study including 155 urine samples obtained from 140 patients with history of NMIBC, the sensitivity (84%) and specificity (91%) of the Xpert BC Monitor were significantly higher than bladder washing cytology (33% and 76%).…”

Section: Introduction: Clinical Issues In Urothelial Carcinoma Of Thementioning

confidence: 93%

“…The Xpert BC Monitor measures five target mRNAs ( ABL1 , CRH , IGF2 , UPK1B , and ANXA10 ) using quantitative real-time PCR 64,65. These markers are related to proliferation and survival ( IGF2 ), neuroendocrine stress response and inflammation ( CRH ), cell growth and signal transduction ( ANXA10 ), and epigenetic dysregulation in BCa ( UPK1B ).…”

Section: Introduction: Clinical Issues In Urothelial Carcinoma Of Thementioning

confidence: 99%

Emerging biomarkers for the diagnosis and monitoring of urothelial carcinoma

Miyake¹,

Owari²,

Nakai³

et al. 2018

RRU

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Urothelial carcinoma (UC) arises extensively from the renal pelvis, ureter, urinary bladder, and urethra. UC represents a clinical and social challenge because of its incidence, post-treatment recurrence rate, and prognosis. Combinations of urine cytology, cystoscopy, and conventional imaging such as computed tomography are currently used for diagnosis and monitoring modalities of UC. Both the poor diagnostic accuracy of urine cytology and poor cost performance of cystoscopy and conventional imaging modalities emphasize the urgent need for advancement in clinical guidance for UC. Urine- and blood-based biomarkers for detection of UC of the bladder and upper urinary tract represent a considerable research area. Biomarkers can help to improve UC diagnosis with the aim of replacing cystoscopy and other imaging examinations in future and may enable individualizing risk stratification regarding therapy and follow-up. Over the decades, numerous studies have focused on the potential application of biomarkers for UC, including urine, circulating tumor DNA, RNAs, proteins, and extracellular vesicles. Although some biomarkers such as ImmunoCyt/uCyt+, UroVysion, NMP-22, bladder tumor antigen, CxBladder, and Xpert Bladder Cancer are currently available in clinical practice, few biomarkers achieve high sensitivity and specificity. Emerging biomarkers are continuously developed and reported in medical journals. However, there is a significant lack on following external validation using different cohorts. The positive results are needed to be confirmed by more studies with large-scale cohorts and long follow-up periods to prove the true value of novel biomarkers, followed by their adoption in clinical practice. The present paper provides an overview of the evidence based on high-impact studies regarding urine- and blood-based biomarkers and their clinical applications in bladder cancer and upper tract UC.

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“…However, none of these markers succeeded in replacing the routine cystoscopy during follow-up. Owing to the recent advancements in molecular technologies, new-generation urine tests, including UroVysion (8,9), CxBladder Monitor (10), Xpert Bladder Cancer Monitor (11), and FGFR3 gene mutation, have been developed (12). A large-scale metaanalysis of the UroVysion test revealed a diagnostic accuracy of 72% sensitivity and 83% specificity (13).…”

mentioning

confidence: 99%

Significant lack of urine-based biomarkers to replace cystoscopy for the surveillance of non-muscle invasive bladder cancer

Miyake

Owari

Fujimoto

2019

Transl. Androl. Urol

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Validation of a mRNA-based urine test for bladder cancer detection in patients with hematuria

Cited by 9 publications

References 0 publications

The role of URO17™ biomarker to enhance diagnosis of urothelial cancer in new hematuria patients—First European Data

The role of URO17™ biomarker to enhance diagnosis of urothelial cancer in new hematuria patients—First European Data

Emerging biomarkers for the diagnosis and monitoring of urothelial carcinoma

Significant lack of urine-based biomarkers to replace cystoscopy for the surveillance of non-muscle invasive bladder cancer

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