Clinical Utility of Oncuria™, a Multiplexed Liquid Biopsy for the Non-Invasive Detection of Bladder Cancer—A Pilot Study

Oncuria™ is a validated quantitative multiplex immunoassay capable of detecting bladder cancer from a voided urine sample. Herein, we sought to determine whether Oncuria™ affects physicians’ use of non-invasive and invasive diagnostic tests for microhematuria, gross hematuria, and bladder cancer surveillance. We conducted a survey-based study to assess physician management of nine clinical scenarios involving real-world data from patients with gross hematuria, microhematuria, and bladder cancer on surveillance. We randomly sampled 15 practicing urologists and generated data including 135 patient-by-urologist interactions and 2160 decision points. Urologists recommended a selection of diagnostic tests and procedures before and after Oncuria™ results were provided. We assessed changes in provider use of non-invasive and invasive diagnostic tests after Oncuria™ results were provided. Over 90% of all urologists changed their diagnostic behavior in at least one patient case with the addition of Oncuria™ results. The total number of diagnostic procedures was reduced by 31% following the disclosure of a negative Oncuria™ test and 27% following the disclosure of a positive Oncuria™ test. This is pilot study has the potential to shed light on the analysis of our four large multicenter international studies deploying OncuriaTM. The Oncuria™ urine-based test, a molecular diagnostic capable of ruling out the presence of bladder cancer, reduces both unnecessary invasive and non-invasive diagnostics and has the potential to reduce costs and improve patient outcomes.

Download Full-text

Application of Health Technology Assessment (HTA) to Evaluate New Laboratory Tests in a Health System: A Case Study of Bladder Cancer Testing

Academic Pathology ◽

10.1177/2374289520968225 ◽

2020 ◽

Vol 7 ◽

pp. 237428952096822

Author(s):

Erik J. Landaas ◽

Ashley M. Eckel ◽

Jonathan L. Wright ◽

Geoffrey S. Baird ◽

Ryan N. Hansen ◽

...

Keyword(s):

Bladder Cancer ◽

Pilot Study ◽

Health Technology Assessment ◽

Technology Assessment ◽

Real World ◽

Health Technology ◽

Test System ◽

Real World Data ◽

World Data

We describe the methods and decision from a health technology assessment of a new molecular test for bladder cancer (Cxbladder), which was proposed for adoption to our send-out test menu by urology providers. The Cxbladder health technology assessment report contained mixed evidence; predominant concerns were related to the test’s low specificity and high cost. The low specificity indicated a high false-positive rate, which our laboratory formulary committee concluded would result in unnecessary confirmatory testing and follow-up. Our committee voted unanimously to not adopt the test system-wide for use for the initial diagnosis of bladder cancer but supported a pilot study for bladder cancer recurrence surveillance. The pilot study used real-world data from patient management in the scenario in which a patient is evaluated for possible recurrent bladder cancer after a finding of atypical cytopathology in the urine. We evaluated the type and number of follow-up tests conducted including urine cytopathology, imaging studies, repeat cystoscopy evaluation, biopsy, and repeat Cxbladder and their test results. The pilot identified ordering challenges and suggested potential use cases in which the results of Cxbladder affected a change in management. Our health technology assessment provided an objective process to efficiently review test performance and guide new test adoption. Based on our pilot, there were real-world data indicating improved clinician decision-making among select patients who underwent Cxbladder testing.

Download Full-text

Urinary expression of let-7c cluster as non-invasive tool to assess the risk of disease progression in patients with high grade non-muscle invasive bladder Cancer: a pilot study

Journal of Experimental & Clinical Cancer Research ◽

10.1186/s13046-020-01550-w ◽

2020 ◽

Vol 39 (1) ◽

Author(s):

Manuela Spagnuolo ◽

Manuela Costantini ◽

Mariaconsiglia Ferriero ◽

Marco Varmi ◽

Isabella Sperduti ◽

...

Keyword(s):

Bladder Cancer ◽

Pilot Study ◽

Disease Progression ◽

Invasive Bladder Cancer ◽

High Grade ◽

Muscle Invasive Bladder Cancer ◽

Non Invasive ◽

Risk Of Disease ◽

Muscle Invasive

Download Full-text

Improved Non-Invasive Diagnosis of Bladder Cancer with an Electronic Nose: A Large Pilot Study

Journal of Clinical Medicine ◽

10.3390/jcm10214984 ◽

2021 ◽

Vol 10 (21) ◽

pp. 4984

Author(s):

PierFrancesco Bassi ◽

Luca Di Gianfrancesco ◽

Luigi Salmaso ◽

Mauro Ragonese ◽

Giuseppe Palermo ◽

...

Keyword(s):

Bladder Cancer ◽

Pilot Study ◽

Sensitivity And Specificity ◽

Electronic Nose ◽

False Negative ◽

Cost Effective ◽

Combination Method ◽

Non Invasive ◽

Phase 2 Study ◽

Sensitivity Specificity

Background: Bladder cancer (BCa) emits specific volatile organic compounds (VOCs) in the urine headspace that can be detected by an electronic nose. The diagnostic performance of an electronic nose in detecting BCa was investigated in a pilot study. Methods: A prospective, single-center, controlled, non-randomized, phase 2 study was carried out on 198 consecutive subjects (102 with proven BCa, 96 controls). Urine samples were evaluated with an electronic nose provided with 32 volatile gas analyzer sensors. The tests were repeated at least two times per sample. Accuracy, sensitivity, specificity, and variability were evaluated using mainly the non-parametric combination method, permutation tests, and discriminant analysis classification. Results: Statistically significant differences between BCa patients and controls were reported by 28 (87.5%) of the 32 sensors. The overall discriminatory power, sensitivity, and specificity were 78.8%, 74.1%, and 76%, respectively; 13/96 (13.5%) controls and 29/102 (28.4%) BCa patients were misclassified as false positive and false negative, respectively. Where the most efficient sensors were selected, the sensitivity and specificity increased up to 91.1% (72.5–100) and 89.1% (81–95.8), respectively. None of the tumor characteristics represented independent predictors of device responsiveness. Conclusions: The electronic nose might represent a potentially reliable, quick, accurate, and cost-effective tool for non-invasive BCa diagnosis.

Download Full-text