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TEST:
UroAmp

Type:
Laboratory Developed Test
Evidence

News

2ms
Urinary comprehensive genomic profiling assists in non-invasive detection and molecular staging of upper tract urothelial carcinoma (AUA 2024)
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.
HER-2 (Human epidermal growth factor receptor 2) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • ARID1A (AT-rich interaction domain 1A) • TERT (Telomerase Reverse Transcriptase) • KMT2D (Lysine Methyltransferase 2D) • CREBBP (CREB binding protein) • STAG2 (Stromal Antigen 2) • SOX4 (SRY-Box Transcription Factor 4)
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PIK3CA mutation • HER-2 mutation • ARID1A mutation • KMT2D mutation • CREBBP mutation • ERBB3 mutation • STAG2 mutation • TERT mutation
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UroAmp
2ms
Minimal residual disease detection supports high-grade bladder cancer risk-stratification during recommended repeat transurethral resection (AUA 2024)
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.
Tumor mutational burden • Minimal residual disease
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TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • RB1 (RB Transcriptional Corepressor 1) • ARID1A (AT-rich interaction domain 1A) • TERT (Telomerase Reverse Transcriptase)
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TP53 mutation • ARID1A mutation • TERT mutation
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UroAmp
2ms
Urinary minimal residual disease detection predicts recurrence in BCG-unresponsive NIMBC and quantifies molecular response to nadofaragene firadenovec (AUA 2024)
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.
Minimal residual disease
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HER-2 (Human epidermal growth factor receptor 2) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • MSI (Microsatellite instability) • ARID1A (AT-rich interaction domain 1A) • ELF3 (E74 Like ETS Transcription Factor 3) • SOX4 (SRY-Box Transcription Factor 4)
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HER-2 mutation
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UroAmp
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Adstiladrin (nadofaragene firadenovec-vncg)
5ms
Urinary minimal residual disease detection predicts recurrence in BCG-unresponsive NIMBC and quantifies molecular response to nadofaragene firadenovec. (ASCO-GU 2024)
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.
Minimal residual disease
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HER-2 (Human epidermal growth factor receptor 2) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • MSI (Microsatellite instability) • ARID1A (AT-rich interaction domain 1A) • ELF3 (E74 Like ETS Transcription Factor 3) • SOX4 (SRY-Box Transcription Factor 4)
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HER-2 mutation
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UroAmp
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Adstiladrin (nadofaragene firadenovec-vncg)
5ms
Correlation of urinary comprehensive genomic profile with risk of recurrence of BCG-unresponsive non-muscle invasive bladder cancer treated with atezolizumab in SWOG S1605. (ASCO-GU 2024)
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.
UroAmp
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Tecentriq (atezolizumab)
6ms
DETECTION, RISK STRATIFICATION, AND THERAPUETIC SELECTION FOR UPPER TRACT UROTHELIAL CARCINOMA WITH URINE-BASED COMPREHENSIVE GENOMIC PROFILING (SUO 2023)
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.
Tumor mutational burden
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TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • FGFR3 (Fibroblast growth factor receptor 3)
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FGFR3 mutation • FGFR3 positive
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UroAmp
7ms
Urinary Comprehensive Genomic Profiling Predicts Urothelial Cancer Up to 12 Years Ahead of Clinical Diagnosis: An Expanded Analysis of the Golestan Cohort Study (AMP 2023)
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.
Clinical
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TERT (Telomerase Reverse Transcriptase)
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TERT mutation
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UroAmp
8ms
Urinary comprehensive genomic profiling predicts urothelial carcinoma recurrence and identifies responders to intravesical therapy. (PubMed, Mol Oncol)
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.
Journal
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UroAmp
8ms
Journal
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UroAmp
9ms
New study shows UroAmp can detect bladder cancer not found by cystoscopy or urine cytology (PRNewswire)
"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."
Clinical data
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UroAmp