TEST:

UroVysion™ Bladder Cancer Kit (UroVysion Kit)

FISH positivity was lower than expected and was positive in PSC patients without CCA. These results question the clinical utility of FISH for CCA surveillance in PSC patients.

Analysis of these genes has been made possible by the development of non-invasive cytogenetic diagnostic tools such as UroVysion FISH. Novel gene therapy for the genes interferon α2b, HER2, and FGFR3, and immunotherapy targeting of frequently mutated transduction pathways are promising treatments.

U-FISH successfully identified all cases of AUC with neoplastic outcomes. In the HGUC group, there was a difference in cases with and without MPI, which requires further confirmation in a larger prospective cohort.

Intravesical T3011 demonstrates a promising anti-tumor efficacy and an excellent safety profile in patients with high risk BCG-failure NMIBC.

Our analysis finds that while these tests may provide some clinical utility, none of the assays have thus far demonstrated objective evidence to supplant the gold diagnostic standard.

The results of this large-scale prospective study support Acu-URO17 as a clinically relevant, non-invasive and cost-effective tool for detecting bladder cancer cells in voided urine specimens. Its high sensitivity, specificity and NPV make it a valuable adjunct to urine cytology and UroVysionâ„¢ FISH in the diagnosis and management of urothelial carcinoma (UC).

The small number of positive FISH results in BB with equivocal cytology raises the question of the optimal criteria for malignancy. Using only polysomy could result in lower sensitivity.

Post-surgery UC-score decreased in 97.7% of subjects. Overall, UI-Seek demonstrated robust performance and considerable potential for the early detection of UC.

Overall FISH testing for detecting malignancy in biliary strictures has a pooled sensitivity of 55.9% and specificity of 88.1%. These test characteristics are impacted by the definition of a positive test. Reporting of FISH testing requires further standardization to avoid false positive test results.

We report a large cohort for comparison of FISH and cytology in detecting malignant biliary strictures. FISH was more sensitive than cytology (84.2% vs 45.8%). FISH rarely produces false positive results (specificity 96.0% vs 100%).

In our experience, the application of TPS criteria for reporting upper urinary cytology was reliable at detecting UUT lesions, especially HGUC. UroVysion FISH was a valuable ancillary test for detecting HGUC of UUT.

The high rate of concordance between the two assays suggests that Biocare's CytoFISH assay is a robust alternative to Abbott's UroVysion in the diagnosis and monitoring of bladder carcinoma.

UroVysion FISH possibly has a high positive rate in CNUL. CNUL and UC have different genetic changes shown by FISH.

P=N/A; Not yet recruiting --> Recruiting

P=N/A; N=800; Not yet recruiting; Sponsor:Ferring Pharmaceuticals

The incidence of UCC in the normal population is .02%. In our study we found that in cases where fewer than 4 cells (2–3) with aneuploidy were detected, they were highly indicative of presence or susceptibility to UCC (19% progressed to UCC). Therefore, our study indicates that follow-up screening for patients with 2–3 aneuploid cells detected in UroVysion assay can lead to detection of a significant number of UCCs.

This study was the first to report the Japanese real-world practice of the UroVysion test, demonstrating relatively low positive rate as compared to the previous reports from other countries. Further clinical evidence from other Japanese institutes needs to be accumulated to update the true value of this test.

"Bladder-Epicheck® and Urovysion®FISH along with cytology could be a helpful ancillary method in the diagnosis and follow-up of UTUC while due to its low specificity Xpert®-BC Detection seems to be of limited usefulness."

These biomarkers have potential for use as a triage tool in community and primary care settings for reducing unnecessary specialist referrals. Despite promising emerging evidence, further validation studies in the general population are required at different stages within the diagnostic pathway.

This study demonstrates the advantage of CellDetect as a urine-based assay to detect urothelial bladder cancer over urine cytology and U-FISH test. The high performance was maintained across all cancer grades and stages without compromising the assay specificity. Additional studies are required to test if it can be a noninvasive alternative to cystoscopy.

"Urinary biomarkers might have a complementary place in bladder cancer diagnosis and NMIBC surveillance. However, their clinical benefit remains to be confirmed."

However, with the continuous enrichment of clinical studies at home and abroad, U-FISH has shown a broader application space in the detection of various urinary primary tumors and even metastatic tumors. This review focuses on summarizing the research status of U-FISH in UC, non-urothelial carcinoma and metastatic tumor, so as to strengthen urologists' more comprehensive understanding of the application value of U-FISH and better complete the accurate diagnosis and treatment of urological cancers.

The molecular profiling of CCA provides better understanding of the pathogenesis of the disease and guidance of the potential targeted therapy. This case study enriches the clinical presentation and molecular profiling of CCA and shines a light on the future treatment of the disease.

The molecular profiling of CCA provides better understanding of the pathogenesis of the disease and guidance of the potential targeted therapy. This case study enriches the clinical presentation and molecular profiling of CCA and shines a light on the future treatment of the disease.

The findings of this study indicate that FISH has a satisfactory sensitivity (68%) and specificity (64%) and could be a potential biomarker in the surveillance of NMIBC. Moreover, BCG treatment and different FISH methods may have an impact on the sensitivity and specificity, these factors should be taken into account when making clinical strategy.

Despite certain biomarkers demonstrated better performance, current diagnostic abilities of the FDA-approved biomarkers remain insufficient for their general application as a rule out test for bladder cancer diagnosis and as a triage test for cystoscopy in patients with primary haematuria. High-quality prospective studies are required to further analyse this and also analyse the correct scenario in which urinary biomarkers may be best utilised.

The SP of FISH was significantly higher. By using FISH and Xpert in addition to cystoscopy, renal and bladder US, and/or CTU in the diagnostic workup of patients with hematuria and follow-up after transurethral resection of the bladder (TURB), a substantial number of patients (10%) otherwise missed were discovered to have UC.

The chromosomal aberrations patterns which we evaluated using FISH; 1) polysomy of chromosomes 3+7 and 2) polysomy of chromosomes 3+7+17 with 9p21 heterozygous loss, have strong potential as indicators of poor prognosis in CCA patients.

This clinical trial was prospectively registered with the Japan Registry of Clinical Trials on 23 June 2021. The reference number is jRCTs051210042, nara0023 (Certified Review Board of Nara Medical University).

Prognosis of bladder cancer is also defined by molecular features such as the claudin and MMP expressions and chromosomal alterations detected by UroVysion test. Last but not least, molecular aberrations are strong predictive factors: high mutation burden defines sensitivity toward immunotherapies, ERCC2 and HER-2 mutations define sensitivity toward chemotherapy, BRCA1/2 mutations define sensitivity to PARP inhibitors, tumors with FGFR3 mutation are prone to FGFR inhibitors while HRAS mutations define sensitivity to farnesyltransferase inhibitors.

In the final step, sections are consecutively cut, stained with hematoxylin-eosin (H&E), and analyzed via UroVysion FISH and immunohistochemistry (IHC). Using our simple and reliable protocol, we can improve the quality of urine specimens, allowing a better collection, maintenance, and analysis of cells, with the advantage of using ancillary tests to support cytological diagnosis and the advantage of storing cellular material in a FFPE-CytoMatrix block.

CellDetect and FISH show equal value in diagnosing UC, both are superior to conventional urine cytology. Compared to FISH, CellDetect is cost effective, easy to operate, with extensive clinical application value to monitor recurrence of UC, and to screen indetectable UC.

In reviewing and analyzing the signal patterns, we noticed trends according to location and diagnosis. Herein we describe our method for analyzing signal patterns and propose cutoff criteria based upon observations gleaned from such analysis.

The aim of this review is to provide a comprehensive overview of the morphological and immunophenotypical aspects of UC-IGP. Moreover, we present and discuss the immunohistochemical and molecular markers involved in diagnosis and prognosis of UC-IGP lesions.

However, variability of results among the different studies was strong. Thus, as of now, none of these markers presented evidences so as to be accepted by international guidelines for diagnosis of BC.

However, room exists for further research, with numerous reports on this test having been recently published. In order to update our knowledge, we herein present a brief overview of UroVysion and its features that follows the latest findings as they relate to UC.

"The Xpert test has a high sensitivity for detecting the recurrence of cancer and a high negative predictive value for excluding HG cancer. In addition, the data suggest that patients with a positive Xpert assay in setting of negative cystoscopy are at high risk for recurrence and need close surveillance."

The UroVysion Kit is designed to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus by FISH in urine specimens from symptomatic patients, those with hematuria suspected of having bladder cancer. Here, the approach for FISH assay by using UroVysion Bladder Cancer kit according to manufacturer's instructions is described.

UroVysion is a specific and relatively sensitive diagnostic tool for separating benign from malignant mesothelial proliferations in cytology and surgical FFPE specimens. This approach is more sensitive than 9p21 FISH alone.

The main biomarker objective should be to rule out high grade tumor recurrence without the need for any invasive procedures. Nevertheless, the clinical implementation of these biomarkers in the follow up of NMIBC has to be further investigated in prospective randomized trials for low as well as high grade tumors.

Our results support TPS's ability to improve the reliability and accuracy of interpretations in urine cytology for HGUC. Nevertheless, additional studies are essential to improve the diagnostic accuracy of LGUN, and urine adequacy, in order to improve patient care and early detection, while identifying potential sampling bias.

Similarly, it is comprehensible that PD-L1 expression by the immune cells plays a complementary role to the tumor in downstream immune inhibition. The high-level PD-L1 expression by the tumor cells and immune cells with clinical response to immunotherapy as demonstrated by our case is exemplary of such roles and hence, improves our understanding of the pathology behind this rare entity.