# MULTIPLEXED PROTEIN BIOMARKER-BASED ASSAY FOR THE DETECTION OF BLADDER CANCER

> **NIH NIH R01** · CEDARS-SINAI MEDICAL CENTER · 2020 · $652,494

## Abstract

Project Summary/Abstract
Background The most common presenting symptom in patients with bladder cancer is hematuria. In two
large studies, 5-8% of patients with microscopic hematuria (> 3 RBC/hpf) were noted to harbor bladder cancer
(BCa). Published guidelines recommend these patients to obtain voided urinary cytology (VUC), in addition
to cystoscopic evaluation. Cystoscopy is an invasive, uncomfortable and expensive procedure associated with
side effects such as transient voiding symptoms, hematuria, UTI, and stenosis of the urethra, whereas, VUC
has limited sensitivity of 25-40% in detecting BCa (specificity is >90%), especially for low-grade and low-stage
tumors. While some commercially available urine-based assays for the detection of BCa are available,
many suffer from a reduction in assay specificity compared to VUC (e.g., NMP-22 and BTA). Furthermore,
as single markers, these assays, including VUC have insufficient predictive power to be applied to the
management of individual patients, and importantly, these techniques are complex, and require skillful
interpretation. The clinical impact of the proposal is to develop a more reliable and standardize assay that can
detect BCa using a voided urine sample. Premise Our central premise is that our bladder cancer (BCa)-
associated diagnostic signature may be successfully adopted to a multiplex bead-based immunoassay
platform and utilized for the detection of BCa. Specific Aims: Specific Aim #1: To refine our prototype
multiplex bead-based immunoassay such that it is enhanced for our ongoing prospective, multicenter
validation studies. Significance If validated, the assay will be incorporated in the current R01 and could
ultimately lead to a reduction in the need to subject large numbers of patients who do not have BCa to
frequent, uncomfortable and expensive cystoscopic examinations. Methodology We will refine and optimize
the multiplex assay and then test it in two large cohorts. prior to being incorporated into the current clinical
trials associated with the R01. Expected Results Within this project, we will transform our prototype multiplex
bead-based immunoassay into the final multiplex bead-based immunoassay that has been analytically and
clinically validated and thus poised to undergo external multiple site validation in the prospective clinical trials
associated with the current R01 grant.

## Key facts

- **NIH application ID:** 9922223
- **Project number:** 5R01CA198887-05
- **Recipient organization:** CEDARS-SINAI MEDICAL CENTER
- **Principal Investigator:** Charles J Rosser
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $652,494
- **Award type:** 5
- **Project period:** 2019-05-01 → 2021-08-04

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9922223

## Citation

> US National Institutes of Health, RePORTER application 9922223, MULTIPLEXED PROTEIN BIOMARKER-BASED ASSAY FOR THE DETECTION OF BLADDER CANCER (5R01CA198887-05). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9922223. Licensed CC0.

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