# Translation of a Clinical Molecular Diagnostic Assay for Bladder Cancer

> **NIH NIH R01** · MAYO CLINIC  JACKSONVILLE · 2020 · $622,819

## Abstract

Project Summary/Abstract
Bladder cancer (BCa) is among the five most common malignancies in the US and worldwide. At presentation,
the majority of bladder tumors are non-muscle invasive and can be treated by transurethral resection of the
tumor; however, more than 70% of patients with BCa will have a recurrence during the first two years after
primary treatment. This recurrence phenomenon makes BCa one of the most prevalent cancers worldwide.
Accordingly, once diagnosed, patients are under continual surveillance with routine cystoscopy for detection of
new tumor development, so the healthcare costs of BCa are a major burden. The overall goal of this project is
to adapt and optimize an efficient assay that can achieve the accurate, non-invasive detection of BCa via
urinalysis.
Using high-throughput proteomic profiling technologies and multiple validation studies, we have defined a
multiplex protein biomarker signature that outperforms any currently used non-invasive approach for BCa
detection. The next task is to develop a specific technology system and achieve through optimization the
translation of the novel assay for clinical molecular diagnosis. To address this, we have created an
academic/industry research partnership between the Mayo Clinic and Meso Scale Diagnostics. The proposal
will test functionality, enable optimization, and validate the performance of the proposed assay in a real-world
clinical laboratory setting. At the end of the study, we aim to have developed a non-invasive, urine-based
assay for bladder cancer detection and disease status evaluation that will be of tremendous benefit to both
patients and the healthcare system.

## Key facts

- **NIH application ID:** 9980305
- **Project number:** 5R01CA206584-04
- **Recipient organization:** MAYO CLINIC  JACKSONVILLE
- **Principal Investigator:** Steve Goodison
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $622,819
- **Award type:** 5
- **Project period:** 2017-08-01 → 2022-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9980305

## Citation

> US National Institutes of Health, RePORTER application 9980305, Translation of a Clinical Molecular Diagnostic Assay for Bladder Cancer (5R01CA206584-04). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/9980305. Licensed CC0.

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