Papillary urothelial neoplasm of low malignant potential

Nucleix Presents Two Bladder EpiCheck® Studies at EAU20 Virtual Congress, Including Interim Data in Patients with Upper Tract Urothelial Cancer

Retrieved on: 
Friday, July 17, 2020
Research, Surgery, Genetics, Clinical trials, Biotechnology, Health, General Health, Science, Oncology, Urology, Neoplasms, Cancer, Bladder cancer, RTT, Transitional cell carcinoma, Transitional epithelium, Urinary bladder, Ureteroscopy, Papillary urothelial neoplasm of low malignant potential, Urine cytology, Bladder EpiCheck®, Nucleix

The first presentation, titled Feasibility of the EpiCheck test in upper tract tumor: interim analysis of a prospective trial, evaluated 47 patients who underwent an ureteroscopy for primary or recurrent upper tract urothelial cancer (UTUC) since June 1, 2018.

Key Points: 
  • The first presentation, titled Feasibility of the EpiCheck test in upper tract tumor: interim analysis of a prospective trial, evaluated 47 patients who underwent an ureteroscopy for primary or recurrent upper tract urothelial cancer (UTUC) since June 1, 2018.
  • This interim analysis reported a significantly higher overall sensitivity of Bladder EpiCheck compared to cytology in voided urine (75% vs 39%, p=0.03).
  • We are encouraged that these data demonstrate the promise of Bladder EpiChecks ability to accurately rule-out high-grade upper tract urothelial cancer with a simple voided urine test.
  • We are building an EpiCheck franchise, beginning with our Bladder EpiCheck testing kit marketed in Europe for bladder cancer recurrence.

UroGen Pharma Receives U.S. FDA Expedited Approval for Jelmyto™, the First and Only Non-Surgical Treatment for Patients with Low-Grade Upper Tract Urothelial Cancer

Retrieved on: 
Wednesday, April 15, 2020
Oncology, FDA, Health, Clinical trials, Pharmaceutical, Biotechnology, Medical specialties, Carcinoma, Transitional cell carcinoma, Anatomy, Urology, Transitional epithelium, Ureter, Urinary system, Urinary tract infection, Papillary urothelial neoplasm of low malignant potential, the Phase 3 OLYMPUS Trial, Jelmyto™ (mitomycin) for pyelocalyceal solution, Upper Tract Urothelial Cancer (UTUC), UroGen Pharma Ltd.

LG UTUC is a rare cancer that develops in the lining of the upper urinary tract, ureters and kidneys.

Key Points: 
  • LG UTUC is a rare cancer that develops in the lining of the upper urinary tract, ureters and kidneys.
  • These programs are for eligible patients who have been prescribed Jelmyto and who need help managing the cost of treatment.
  • Jelmyto (mitomycin) for pyelocalyceal solution is a drug formulation of mitomycin for the treatment of low-grade upper tract urothelial cancer (LG UTUC).
  • Browne BM, Stensland KD, Moynihan MJ, Canes D. An Analysis of Staging and Treatment Trends for Upper Tract Urothelial Carcinoma in the National Cancer Database.

QIAGEN Launches First FDA-Approved Companion Diagnostic Using FGFR Alterations to Help Guide the Treatment of Metastatic Urothelial Cancer

Retrieved on: 
Friday, April 12, 2019
Health, Biotechnology, Clinical trials, Genetics, Medical devices, Oncology, FDA, Neoplasms, Carcinoma, Transitional cell carcinoma, Clinical medicine, Aging-associated diseases, RTT, Medicine, Transitional epithelium, Qiagen, Cancer, Papillary urothelial neoplasm of low malignant potential

Urothelial cancer begins in tissues lining the bladder and other genitourinary organs and is the sixth most common type of cancer in the United States.

Key Points: 
  • Urothelial cancer begins in tissues lining the bladder and other genitourinary organs and is the sixth most common type of cancer in the United States.
  • A percentage of urothelial carcinoma tumors have certain FGFR alterations which are thought to be key drivers of tumor growth.
  • Detection of these alterations utilizing the companion diagnostic will help identify patients eligible for treatment with BALVERSA.
  • The therascreen FGFR Kit co-approval with BALVERSA marks the sixth FDA approval of a therapy with a QIAGEN companion diagnostic assay.

Cxbladder™ Monitor Demonstrates Clinical Utility In Patients Being Monitored For Recurrent Bladder Cancer (UC)

Retrieved on: 
Thursday, May 24, 2018
Medicine, Cancer, Clinical medicine, RTT, Epithelium, Urothelium, Transitional cell carcinoma, Cystoscopy, Papillary urothelial neoplasm of low malignant potential, Bladder cancer

The recent published study highlights the clinical utility of Pacific Edge's non-invasive cancer diagnostic test, Cxbladder Monitor, with results showing a significant reduction in the number of tests ordered by physicians when using Cxbladder Monitor for the detection or rule-out of recurrent urothelial cancer1.

Key Points: 
  • The recent published study highlights the clinical utility of Pacific Edge's non-invasive cancer diagnostic test, Cxbladder Monitor, with results showing a significant reduction in the number of tests ordered by physicians when using Cxbladder Monitor for the detection or rule-out of recurrent urothelial cancer1.
  • Participant physicians in the US evaluated the real-world clinical data for patients undergoing surveillance for recurrent urothelial cancer, generating a total of 828 physician-patient decisions.
  • For patients whose Cxbladder Monitor result showed a low probability of recurrent cancer, the number of tests ordered by physicians was reduced by 38.7%, including a reduction in invasive cystoscopy procedures of 43%.
  • While treatable, urothelial cancer has one of the highest recurrence rates of any cancer and patients undergo a rigorous surveillance program.