# APPLICATION OF A MULTIPLEXED IMMUNOASSAY FOR THE DETECTION OF BLADDER CANCER

> **NIH NIH UH3** · CEDARS-SINAI MEDICAL CENTER · 2022 · $458,020

## Abstract

Project Summary/Abstract
Background The non-invasive diagnosing of bladder cancer in patients with hematuria, the most common
clinical presentation of bladder cancer, or in subjects with a history of bladder cancer on tumor surveillance
remains a challenge, and as such, these patients require invasive testing. Current urine-based assays are not
robust and therefore cannot be used to ‘rule out’ patients who do not require these invasive testing.
Previously, we a) identified a bladder cancer-associated diagnostic protein “fingerprint” comprised of 10
biomarkers, b) developed a multiplex immunoassay to query these 10 biomarkers in voided urine samples and
c) performed analytical validation of the multiplex immunoassay. Using the multiplex immunoassay, we have
generated encouraging preliminary data in 326 subjects (46 cancer) noting a sensitivity and specificity of 93%.
Thus, for the first time, we possess an accurate assay that can be used to ‘rule out’ patients who do not require
invasive testing. Furthermore, early detection (i.e., detection prior to clinical manifestation) is an important goal
for patients at risk for bladder cancer. At presentation, more than 70% of bladder cancer cases are non-
muscle invasive bladder cancer (NMIBC), whilst the remaining 30% are muscle invasive bladder cancer
(MIBC) or metastatic. When detected early (i.e., NMIBC), the 5-year survival rate is approximately 94%,
compared to a 5-year survival rate of ~50% when the disease is detected as muscle invasive bladder cancer
(MIBC), and <20% when the disease is metastatic. However, to date, no early detection assay is available. In a
small cohort of 20 bladder cancer patients and 20 matched controls from our ongoing R01 studies, we have
noted an elevation in our bladder cancer-associated diagnostic protein “fingerprint” as early as 18 months prior
to the clinical diagnosis of bladder cancer and an actual positive multiplex immunoassay in all bladder cancer
patients 12 months prior to the clinical diagnosis of bladder cancer. Hypothesis: A bladder cancer-associated
diagnostic protein “fingerprint” exists that can be leveraged to indicate the presence of bladder cancer in non-
invasively obtained urine samples not only at the time of diagnosis, but prior to the clinical presentation and
diagnosis of bladder cancer. Specific Aims: 1) To validate the multiplex immunoassay for bladder cancer
detection in a large, nested case-control study (n=800) and 2) To evaluate the multiplex immunoassay for early
detection in a large, nested case-control study (n=600). Significance This research will open the door for
improving on the non-invasive methods for detecting bladder cancer and as such it will have a marked
impact on patient care. Methodology Previously, our group has discovered and performed early validation of
bladder cancer-associated diagnostic protein” fingerprint’ with extremely encouraging results. In the current
proposal, we now seek to test the multiplex immunoassay in ...

## Key facts

- **NIH application ID:** 10455967
- **Project number:** 1UH3CA271377-01
- **Recipient organization:** CEDARS-SINAI MEDICAL CENTER
- **Principal Investigator:** Charles J Rosser
- **Activity code:** UH3 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $458,020
- **Award type:** 1
- **Project period:** 2022-06-20 → 2025-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10455967

## Citation

> US National Institutes of Health, RePORTER application 10455967, APPLICATION OF A MULTIPLEXED IMMUNOASSAY FOR THE DETECTION OF BLADDER CANCER (1UH3CA271377-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10455967. Licensed CC0.

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