TEST:

UroAmp

P2; Urinary MRD testing after nadofaragene firadenovec induction provided statistically significant prognostication of recurrence among phase 2 trial participants.

P3; N=200; Not yet recruiting; Sponsor:Johns Hopkins University

uCGP can identify genomic features associated with UTUC and provide definitive results in cases of atypical cytology. Unique genomic patterns provide insight into tumor grade and origin. This study suggests uCGP can provide diagnostic and prognostic information for the evaluation for UTUC.

These results support uCGP-guided risk-stratification of HG UCB patients undergoing re-TURBT. MRD detection provides prognostic information for multifocal and visually occult disease.

uMRD enables quantitative assessment of molecular response to drug treatment. uMRD-determined pre-treatment disease burden assessment can support stratification of control and intervention arms in future treatment trials.

uMRD enables quantitative assessment of molecular response to drug treatment. uMRD-determined pre-treatment disease burden assessment can support stratification of control and intervention arms in future treatment trials.

This study suggests that uCGP at baseline and after 4 cycles of treatment can identify genomic patterns associated with an increased risk of HG persistence, recurrence or progression in BU NMIBC treated with immune checkpoint inhibition. Future studies will determine if this can be used to guide early treatment intensification.

uCGP provides clinicians with diagnostic and prognostic insights into their patient's disease. This is of particular importance in UTUC where lesions are often small and difficult to detect, stage, and thus treat. uCGP can be used to appropriately risk stratify patients and can identify patients who may benefit from first line systemic therapy, versus immediate surgery, based on FGFR3 and MSI/TMB status.

Our results provide the first evidence from a populationbased prospective cohort study of preclinical UC detection with muCGP. muCGP identifies 9 of 10 cancers that occur within the first 5 years and detects 10 of 19 cancers that occur beyond five years. Further studies will determine the frequency of muCGP screening required to maximize cancer detection and refine clinical interventions to save lives.

Collectively, uCGP enables noninvasive risk assessment of patients following TURBT and induction IVT. uCGP could inform surveillance cystoscopy schedules and identify high-risk patients in need of additional therapy.

uCGP enables noninvasive, accurate UC diagnosis and risk stratification in both hematuria and UC surveillance patients.

"UroAmp, the noninvasive genomic urine test developed by Convergent Genomics, can detect bladder cancer or predict its recurrence before clinical signs or symptoms appear, according to a newly published study in the journal Clinical Cancer Research...In a multi-center case-control study, researchers from leading academic centers and urology practices throughout the United States* compared UroAmp's diagnostic and prognostic performance for bladder cancer to standard-of-care procedures, like cystoscopy, cytology and pathology."