TEST:

Cxbladder

"Pacific Edge...today announces its Dunedin laboratory has signed a service agreement with Singapore General Hospital (SGH), an important milestone in the company’s strategy to drive the adoption of its tests in the Asia Pacific...Physicians and clinicians at SGH may now order Cxbladder Triage or Triage Plus for the evaluation of patients presenting with hematuria, and Cxbladder Monitor for the surveillance of bladder cancer recurrence."

P=N/A, N=107, Completed, Mayo Clinic | Active, not recruiting --> Completed

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.

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.

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.

Triage Plus demonstrated clinical validity in veteran patients with hematuria, with improved sensitivity and specificity compared with earlier assays.

P=N/A, N=1000, Recruiting, Pacific Edge Limited | Trial completion date: Dec 2025 --> Mar 2026 | Trial primary completion date: Dec 2025 --> Mar 2026

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.

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

P=N/A, N=1000, Recruiting, Pacific Edge Limited | Trial completion date: Mar 2025 --> Dec 2025 | Trial primary completion date: Mar 2025 --> Dec 2025

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

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.