Oncuria® is the first-of-its-kind multiplex protein-based immunoassay to provide early detection, therapy choice, and disease monitoring of bladder cancer. This 10-biomarker test has been developed for the early detection of bladder cancer in patients presenting with hematuria or with a history of bladder cancer on disease surveillance. The immunoassay is performed using Luminex ® xMAP technology. The physical components of multiplex assay, a library of detection and capture antibodies, and the secondary reagents have undergone extensive optimization for consistent implementation. Analytical validation of the test has assessed selectivity, sensitivity, specificity, accuracy, linearity, dynamic range, and detection threshold, using voided urine as the test matrix.
Sensitivity and specificity
A combinatorial analysis of all 10 biomarkers achieved a sensitivity of 93% and a specificity of 93% when 3 key clinical factors (age, race, and gender) were included in the clinical nomogram.
Assess the risk of bladder cancer in patients with:
- A history of bladder cancer who are cancer free or on tumor surveillance and who do not have chronic kidney disease (GFR <45 mL/min)
- Hematuria and without chronic kidney disease
- Non–muscle-invasive bladder cancer who will be treated with intravesical BCG therapy and do not have chronic kidney disease
Samples collection and processing:
- Midstream voided urine collected in sterile specimen container
- Store at 4 °C until processed
- Output the results from Luminex
- PAI-1, SERPIN E1
- A1AT, SERPIN A1