UTUC

Pangea Laboratory Receives FDA Breakthrough Device Designation for the Bladder CARE™ Assay

Retrieved on: 
Wednesday, December 20, 2023
Food, Urinary bladder, UTUC, Real-time, Bladder cancer, FDA, Carcinoma, DNA, Hematuria, Cancer, Neoplasm, Methylation, Biomarker, Patient, Clinical research, USC

TUSTIN, Calif., Dec. 20, 2023 /PRNewswire/ -- Pangea Laboratory has received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its non-invasive Bladder CARE™ Assay, intended for the quantitative urine-based diagnosis of bladder cancer and upper tract urothelial carcinoma (UTUC) in patients presenting with hematuria and suspected of having either cancer.

Key Points: 
  • TUSTIN, Calif., Dec. 20, 2023 /PRNewswire/ -- Pangea Laboratory has received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its non-invasive Bladder CARE™ Assay , intended for the quantitative urine-based diagnosis of bladder cancer and upper tract urothelial carcinoma (UTUC) in patients presenting with hematuria and suspected of having either cancer.
  • The Bladder CARE™ Assay measures the methylation levels of three urothelial cancer-specific DNA biomarkers in a single qPCR reaction.
  • "We anticipate further fruitful partnerships with experts in the field to enhance the accessibility of the Bladder CARE™ Assay."
  • Pangea Laboratory is poised to commence multicenter clinical trials as the next step toward obtaining premarket approval for the Bladder CARE™ Assay.

Retrospective Study Finds JELMYTO® Use Effective Following Partial Ablation or Biopsy in Larger Volume Low-Grade Upper Tract Urothelial Tumors that Impede Kidney Preservation

Retrieved on: 
Monday, July 10, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, General Health, Health, Clinical Trials, Neoplasm, Nephrectomy, RDF, Associate, Mitomycins, URS, UTUC, Patient, Role, Biopsy, Pharmaceutical industry, Medical imaging, Nursing, Urology

This study assessed the efficacy of JELMYTO in managing patients with larger volume disease where initial tumor burden may not be amenable to complete mechanical ablation or renal preservation.

Key Points: 
  • This study assessed the efficacy of JELMYTO in managing patients with larger volume disease where initial tumor burden may not be amenable to complete mechanical ablation or renal preservation.
  • The goal of this study was to explore alternatives to nephroureterectomy for patients with higher-volume low-grade disease to preserve kidney function and minimize complications.
  • This study aimed to determine if higher volume, low-grade upper tract urothelial tumors (LG-UTUC) patients could achieve disease-free status by undergoing partial ablation or biopsy only before treatment with JELMYTO during the initial ureteroscopy (URS) procedure.
  • Among the 112 renal units evaluated, 50 underwent complete ablation, 42 underwent partial ablation and 20 underwent biopsy only.

UroGen Pharma Meets Revenue Goal, Reports First Quarter 2023 Financial Results and Recent Corporate Developments

Retrieved on: 
Thursday, May 11, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, Ureter, American Urological Association, Society, Investment, Software, AUA, New Drug Application, Clinical trial, NDA, RNU, SUO, Mitomycins, UTUC, Patient, OLYMPUS, Physician, Guideline, RTW, Webcast, Growth, LG, Neoplasm, Conference, Safety, ATLAS, Pharmaceutical industry, Medical imaging, Video game, Bank, Mitomycin C

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced financial results for the first quarter ended March 31, 2023, and provided an overview of recent developments.

Key Points: 
  • UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced financial results for the first quarter ended March 31, 2023, and provided an overview of recent developments.
  • Generated net product revenue of $17.2 million for the first quarter of 2023, representing ~27% growth over the first quarter of 2022.
  • Activated sites on May 1, 2023 were 1,009, compared to 983 on March 1, 2023, while repeat accounts on May 1, 2023 were 235, compared to 214 on March 1, 2023.
  • First Quarter 2022 Financial Results:
    Jelmyto Revenue: UroGen reported net product revenue of Jelmyto for the first quarter 2023 of $17.2 million, compared to $13.6 million in the first quarter of 2022.

First Study to Evaluate JELMYTO® Use Post-Complete Endoscopic Ablation Reports 69% of Patients were Disease Free at the Time of First Endoscopic Evaluation

Retrieved on: 
Monday, May 1, 2023
Research, Surgery, Health Technology, Biotechnology, Health, Pharmaceutical, Other Science, Science, Oncology, The Journal of Urology, Safety, American Urological Association, UTUC, Stenosis, Estate (law), Adjuvant, Patient, OLYMPUS, Journal, LG, Recurrence, Bias, Treatment, Pharmaceutical industry, Nursing, Medical imaging, Urology

Early failure is a drawback for endoscopic ablation alone, which occurs in 40-50% of UTUC patients by three months.

Key Points: 
  • Early failure is a drawback for endoscopic ablation alone, which occurs in 40-50% of UTUC patients by three months.
  • Response at primary endoscopic evaluation was defined as no visual tumor or negative biopsy.
  • The rate of ureteral stenosis for those in this study who underwent complete endoscopic ablation followed by JELMYTO treatment was 23%.
  • Ureteral stenosis was defined as a condition requiring ureteral stent or nephrostomy, or that would typically warrant stent or nephrostomy.

Predicine to Introduce PredicineALERT™ MRD Assay and Present Two ctDNA Studies in Genitourinary Cancers at AUA 2023 Annual Meeting

Retrieved on: 
Friday, April 28, 2023
DNA, Nucleic acid thermodynamics, TAT, AUA, NMIBC, Liquid biopsy, GU, American Urological Association, Bladder cancer, Index, MRD, UTUC, Patient, Cancer, Annual general meeting, H. Lee Moffitt Cancer Center & Research Institute, CDX, Medical imaging

HAYWARD, Calif., April 28, 2023 (GLOBE NEWSWIRE) -- Predicine, a global molecular insights company, announced today that it will present two studies and introduce PredicineALERT™ Minimal Residual Disease (MRD) liquid biopsy assay to genitourinary (GU) cancers at the 2023 American Urological Association (AUA) Annual Meeting held in Chicago between April 28 to May 1, 2023.

Key Points: 
  • HAYWARD, Calif., April 28, 2023 (GLOBE NEWSWIRE) -- Predicine, a global molecular insights company, announced today that it will present two studies and introduce PredicineALERT™ Minimal Residual Disease (MRD) liquid biopsy assay to genitourinary (GU) cancers at the 2023 American Urological Association (AUA) Annual Meeting held in Chicago between April 28 to May 1, 2023.
  • In collaboration with Moffitt Cancer Center, Predicine will present a podium presentation and two posters demonstrating the clinical utility and potential of Predicine’s liquid biopsy platform in bladder cancer and other solid tumors.
  • Highlights from the studies include PredicineCARE™, urinary tumor DNA detection in treatment-naïve upper tract urothelial carcinoma (UTUC).
  • “Currently, we are working closely with leading biopharma partners and KOLs on liquid biopsy studies in support of clinical trials, CDx development and commercialization.”

New Retrospective Study Presented at AUA 2023 Provides Evidence of Similar Outcomes Utilizing JELMYTO® in the Treatment of UTUC of the Ureter and Renal Pelvis  

Retrieved on: 
Sunday, April 30, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, General Health, Health, Clinical Trials, Ureter, Urine, Stenosis, Safety, Neoplasm, Efficacy, American Urological Association, Mitomycins, UTUC, State University of New York Upstate Medical University, OLYMPUS, Patient, Kidney, LG, Abstract, Treatment, Pharmaceutical industry, Medical imaging

The study titled, First Analysis of the Safety and Efficacy of UGN-101 in the Treatment of Ureteral Tumors (Abstract PD24-07) is the first to assess JELMYTO in treating ureteral tumors.

Key Points: 
  • The study titled, First Analysis of the Safety and Efficacy of UGN-101 in the Treatment of Ureteral Tumors (Abstract PD24-07) is the first to assess JELMYTO in treating ureteral tumors.
  • The investigators reported no difference in outcomes at first endoscopic evaluation based on UTUC tumor location (ureter vs. renal pelvis) (p=0.644).
  • JELMYTO is approved for the treatment of low-grade upper tract urothelial cancer (LG-UTUC) in adult patients.
  • “These data are promising for LG-UTUC patients with ureteral tumors,” said Mark Schoenberg, M.D., Chief Medical Officer, UroGen.

American Urological Association Releases Non-Metastatic Upper Tract Urothelial Carcinoma Guideline

Retrieved on: 
Tuesday, April 25, 2023
Ureter, Survival, UTUC, Diagnosis, Cancer, Mortality, Bladder cancer, Estate (law), Patient, MD, Memorial Sloan Kettering Cancer Center, Guideline, Disease, Pharmaceutical industry, Medical device

UTUC is a rare disease, posing unique challenges to clinical management and significant risks to patients – both from the disease and treatment forms.

Key Points: 
  • UTUC is a rare disease, posing unique challenges to clinical management and significant risks to patients – both from the disease and treatment forms.
  • UTUC is a cancer in either the inner lining of the ureter, calyces, or renal pelvis.
  • Clinicians will not only learn how to evaluate patients, but they will get the most up to date information on treatment, surveillance, survivorship and more."
  • This guideline has 38 recommendations and serves as a useful reference on the effective evidence-based diagnosis and management of non-metastatic UTUC.

New Studies on Convergent Genomics' Urine Test for Bladder Cancer to be Presented at 2023 American Urological Association (AUA) Annual Meeting

Retrieved on: 
Tuesday, April 25, 2023
DNA, Genomics, AUA, American Urological Association, Bladder cancer, UTUC, MD, Urology, Machine learning, Risk, Diagnosis, Recurrence, Genome, Dietary supplement

CHICAGO, April 25, 2023 /PRNewswire/ -- Convergent Genomics announced UroAmp , the company's genomic urine test that uses next-generation DNA sequencing and machine learning to detect and monitor for bladder cancer, will be the subject of two new studies being presented at the 2023 American Urological Association (AUA) Annual Meeting in Chicago.

Key Points: 
  • CHICAGO, April 25, 2023 /PRNewswire/ -- Convergent Genomics announced UroAmp , the company's genomic urine test that uses next-generation DNA sequencing and machine learning to detect and monitor for bladder cancer, will be the subject of two new studies being presented at the 2023 American Urological Association (AUA) Annual Meeting in Chicago.
  • "The evidence continues to mount that urinary comprehensive genomic profiling with UroAmp has an important role to play in the diagnosis and surveillance of bladder cancer.
  • For instance, the studies being presented at AUA 2023 show an ability to predict who is likely to develop bladder cancer in the future, and an ability to detect upper tract disease from a urine sample.
  • These are entirely novel tools which provide clinically useful information to urologists," said Brian Mazzarella, MD, Chief Medical Officer, Convergent Genomics .

Results of the First Post-Commercial Utilization Review of JELMYTO® Provide New Evidence that Reinforces its Efficacy and Safety in Patients with Low-Grade Upper Tract Urothelial Cancer

Retrieved on: 
Wednesday, January 11, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Plasma protein binding, Urology, Olympus, Neoplasm, Treatment, CR, Patient, Observation, Physician, UTUC, Mitomycins, Pharmaceutical industry, Medical imaging, OLYMPUS

The study titled, “Early Experience with UGN-101 for the Treatment of Upper Tract Urothelial Cancer – A Multi-Center Evaluation of Practice Patterns and Outcomes,” is published in Urologic Oncology: Seminars and Original Investigations.

Key Points: 
  • The study titled, “Early Experience with UGN-101 for the Treatment of Upper Tract Urothelial Cancer – A Multi-Center Evaluation of Practice Patterns and Outcomes,” is published in Urologic Oncology: Seminars and Original Investigations.
  • The authors describe several trends in JELMYTO use that differ from the pivotal Olympus study that led to drug approval.
  • JELMYTO is indicated for the treatment of adult patients with low-grade upper tract urothelial cancer (LG-UTUC).
  • Almost half of the patients in the review were treated by antegrade administration of JELMYTO through a nephrostomy tube.

UroGen Pharma Reports Third Quarter 2022 Financial Results and Recent Corporate Developments

Retrieved on: 
Thursday, November 10, 2022
Medical Devices, Medical Supplies, Hospitals, Clinical Trials, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Oncology, Adult, Clothing, Risk, Transitional epithelium, Patient Information Advisory Group, Stomach, Company, Pharmakon—Danish College of Pharmacy Practice, Kidney, Recurrence, Blood, Ureter, Swelling, Birth, Urination, Urinary tract infection, SEC, NMIBC, Water, Time, Cancer, Orphan drug, Neoplasm, Patient, UTUC, Urine, COVID-19, Vomiting, Private Securities Litigation Reform Act, Sodium bicarbonate, Bone marrow, Medicine, Clinical trial, Breast milk, Fatigue, Skin, Growth, Abdomen, Nausea, Perforation, NDA, FDA, Trial of the century, Urinary bladder, Fever, Technology, View, Man, Safety, Female, Pain, Transitional cell carcinoma, Nephrectomy, Pharmaceutical industry, Medical imaging, Health insurance, Birth control, Tanning (leather), Phosphorus, Generic drug, Mitomycins, Mitomycin C

The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.

Key Points: 
  • The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.
  • You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.
  • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO.
  • JELMYTO and UroGen are registered trademarks of UroGen Pharma Ltd.
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