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    TEST:
    Cxbladder

    Company:
    Pacific Edge
    Type:
    Laboratory Developed Test
    Details
    Evidence

    News

    10d
    Urine-based Molecular Testing vs Cystoscopy for Surveillance of Nonmuscle Invasive Bladder Cancer (NMIBC) (clinicaltrials.gov)
    P=N/A, N=107, Completed, Mayo Clinic | Active, not recruiting --> Completed
    Trial completion
    |
    Cxbladder
    13d
    Real-World Utility of Cxbladder Triage for Patients with Microhematuria: A Matched Cohort Study. (PubMed, Urol Pract)
    Cxbladder Triage testing decreases burden of cystoscopy and CT urogram use among microhematuria patients. This test maintains similar cancer detection overall and among microhematuria patients at greater risk for underlying malignancy.
    Journal • Real-world evidence
    |
    Cxbladder
    1m
    Urinary biomarkers in multicentric studies: Shaping the future of bladder cancer diagnosis and follow-up. (PubMed, BJUI Compass)
    Urine-based biomarkers have the potential to improve early BC detection and surveillance while reducing reliance on invasive procedures and costs related to the disease. Future efforts should prioritize cost-effective, large-scale multicentric studies to facilitate the adoption of these biomarkers into routine practice.
    Review • Journal
    |
    AssureMDx • Cxbladder
    2ms
    Urinary extracellular vesicles for high-precision bladder cancer subtyping and prognosis. (PubMed, medRxiv)
    The prognostic score stratified patients into low-, intermediate-, and high-grade risk groups based on Xena's bladder cancer survival outcomes. Our AI-driven uEV liquid biopsy pipeline proves the concept for high precision bladder cancer subtyping and prognosis, which could potentially facilitate treatment decision and lead to advanced profiling of bladder tumor biology using uEV liquid biopsy.
    Journal
    |
    Cxbladder
    3ms
    Diagnostic performance of Cxbladder Triage Plus for the identification and stratification of patients at risk for urothelial carcinoma: The multicenter, prospective, observational DRIVE study. (PubMed, Urol Oncol)
    Triage Plus demonstrated clinical validity in veteran patients with hematuria, with improved sensitivity and specificity compared with earlier assays.
    Observational data • Journal
    |
    FGFR3 (Fibroblast growth factor receptor 3) • TERT (Telomerase Reverse Transcriptase)
    |
    Cxbladder
    3ms
    microDRIVE: Detection and Risk Stratification in Veterans Presenting With Microscopic Hematuria (clinicaltrials.gov)
    P=N/A, N=1000, Recruiting, Pacific Edge Limited | Trial completion date: Dec 2025 --> Mar 2026 | Trial primary completion date: Dec 2025 --> Mar 2026
    Trial completion date • Trial primary completion date
    |
    Cxbladder
    6ms
    Analytical Validation of the Cxbladder® Triage Plus Assay for Risk Stratification of Hematuria Patients for Urothelial Carcinoma. (PubMed, Diagnostics (Basel))
    Triage Plus showed good reproducibility (87.9% concordance between laboratories). Cxbladder Triage Plus accurately and reproducibly detected FGFR3 and TERT SNVs and, in combination with mRNA expression, provides a non-invasive, highly sensitive, and reproducible tool that aids in risk stratification of patients with hematuria.
    Journal
    |
    FGFR3 (Fibroblast growth factor receptor 3) • TERT (Telomerase Reverse Transcriptase)
    |
    Cxbladder
    8ms
    Urine-based Molecular Testing vs Cystoscopy for Surveillance of Nonmuscle Invasive Bladder Cancer (NMIBC) (clinicaltrials.gov)
    P=N/A, N=107, Active, not recruiting, Mayo Clinic | Recruiting --> Active, not recruiting | Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2024 --> Nov 2025
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    Cxbladder
    8ms
    microDRIVE: Detection and Risk Stratification in Veterans Presenting With Microscopic Hematuria (clinicaltrials.gov)
    P=N/A, N=1000, Recruiting, Pacific Edge Limited | Trial completion date: Mar 2025 --> Dec 2025 | Trial primary completion date: Mar 2025 --> Dec 2025
    Trial completion date • Trial primary completion date
    |
    Cxbladder
    8ms
    STRATA: Safe Testing of Risk for AsymptomaTic MicrohematuriA (clinicaltrials.gov)
    P=N/A, N=554, Completed, Pacific Edge Limited | Active, not recruiting --> Completed | Trial completion date: Dec 2024 --> Jul 2024 | Trial primary completion date: Dec 2024 --> Jul 2024
    Trial completion • Trial completion date • Trial primary completion date • Real-world evidence
    |
    Cxbladder
    9ms
    Novel Urinary Biomarkers for the Detection of Bladder Cancer. (PubMed, Cancers (Basel))
    Urinary biomarkers provide a promising noninvasive alternative for traditional BCa diagnostics with enhanced specificity and the possibility of early diagnosis. Future research should focus on large-scale clinical validation and standardization of biomarkers to facilitate their use in routine clinical practice.
    Review • Journal
    |
    Bladder EpiCheck® • Cxbladder • UroSEEK
    10ms
    CREDIBLE: Study to Assess the Impact of the Urine Test Cxbladder Triage Plus on the Number of Cystoscopies Performed on Patients With Invisible Blood in Their Urine. (clinicaltrials.gov)
    P=N/A, N=1000, Recruiting, Pacific Edge Limited | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Cxbladder