Accurate
urinary assays for bladder cancer (BCa) detection would benefit both patients
and healthcare systems. Through genomic and proteomic profiling of urine
components, we have previously identified a panel of biomarkers that can
outperform current urine-based biomarkers for the non-invasive detection of
BCa. Herein, we report the diagnostic utility of various multivariate
combinations of these biomarkers. We performed a case-controlled validation
study in which voided urines from 127 patients (64 tumor bearing subjects) were
analyzed. The urinary concentrations of 14 biomarkers (IL-8, MMP-9, MMP-10,
SDC1, CCL18, PAI-1, CD44, VEGF, ANG, CA9, A1AT, OPN, PTX3, and APOE) were
assessed by enzyme-linked immunosorbent assay (ELISA). Diagnostic performance
of each biomarker and multivariate models were compared using receiver
operating characteristic curves and the chi-square test. An 8-biomarker model
achieved the most accurate BCa diagnosis (sensitivity 92%, specificity 97%),
but a combination of 3 of the 8 biomarkers (IL-8, VEGF, and APOE) was also
highly accurate (sensitivity 90%, specificity 97%). For comparison, the
commercial BTA-Trak ELISA test achieved a sensitivity of 79% and a specificity
of 83%, and voided urine cytology detected only 33% of BCa cases in the same
cohort. These datashow that a multivariate urine-based assay can markedly
improve the accuracy of non-invasive BCa detection. Further validation studies
are under way to investigate the clinical utility of this panel of biomarkers for
BCa diagnosis and disease monitoring.
Source:
A Multi-Analyte Assay for the Non-Invasive Detection of Bladder Cancer.
Steve Goodison, Myron Chang, Yunfeng Dai, Virginia Urquidi, Charles J. Rosser.
Plos One 7(10): e47469.
Free
paper available at:
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RépondreSupprimerFollowing gene identification and algorithm development, a process for conducting the assay, including all steps from receipt of the tumor specimen to generation of the assay result, was finalized and analytically validated prior to conducting clinical validation studies. Analytical validation of Oncotype DX test ensures that the assay will give accurate, precise and reproducible results across different reagent lots, operators, and patient samples. Standardization of the assay is critical to ensuring that the Oncotype DX assay yields reliable results which clinicians can use to informing patient management treatment decisions.
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Cancer Assays
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