Expanded Performance Comparison of the Oncuria 10-Plex Bladder Cancer Urine Assay Using Three Different Luminex xMAP Instruments

TL;DR

This study shows that the Oncuria bladder cancer urine test works reliably across three different lab instruments, making it easier for labs to adopt.

Contribution

Demonstrates consistent performance of the Oncuria assay across three Luminex xMAP instruments using a larger clinical sample set.

Findings

All three instruments showed excellent agreement in measuring 10 protein biomarkers in urine.

Percent coefficient of variation was ≤2.3% for 9 out of 10 biomarkers across instruments.

Standard curve slopes for all biomarkers were statistically indistinguishable between instruments.

Abstract

Background/Objectives: The clinically validated multiplex Oncuria bladder cancer (BC) assay quickly and noninvasively identifies disease risk and tracks treatment success by simultaneously profiling 10 protein biomarkers in voided urine samples. Oncuria uses paramagnetic bead-based fluorescence multiplex technology (xMAP®; Luminex, Austin, TX, USA) to simultaneously measure 10 protein analytes in urine [angiogenin, apolipoprotein E, carbonic anhydrase IX (CA9), interleukin-8, matrix metalloproteinase-9 and -10, alpha-1 anti-trypsin, plasminogen activator inhibitor-1, syndecan-1, and vascular endothelial growth factor]. Methods: In a pilot study (N = 36 subjects; 18 with BC), Oncuria performed essentially identically across three different common analyzers (the laser/flow-based FlexMap 3D and 200 systems, and the LED/image-based MagPix system; Luminex). The current study compared Oncuria performance across instrumentation platforms using a larger study population (N = 181 subjects; 51 with BC). Results: All three analyzers assessed all 10 analytes in identical samples with excellent concordance. The percent coefficient of variation (%CV) in protein concentrations across systems was ≤2.3% for 9/10 analytes, with only CA9 having %CVs > 2.3%. In pairwise correlation plot comparisons between instruments for all 10 biomarkers, R2 values were 0.999 for 15/30 comparisons and R2 ≥ 0.995 for 27/30 comparisons; CA9 showed the greatest variability (R2 = 0.948–0.970). Standard curve slopes were statistically indistinguishable for all 10 biomarkers across analyzers. Conclusions: The Oncuria BC assay generates comprehensive urinary protein signatures useful for assisting BC diagnosis, predicting treatment response, and tracking disease progression and recurrence. The equivalent performance of the multiplex BC assay using three popular analyzers rationalizes test adoption by CLIA (Clinical Laboratory Improvement Amendments) clinical and research laboratories.

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