# Biomarker Development Laboratory

> **NIH NIH U2C** · JOHNS HOPKINS UNIVERSITY · 2024 · $334,030

## Abstract

Active surveillance (AS), which holds off on treatment for low-risk PCa patients until signs of progression are
detected through careful monitoring, was developed as a potential solution to decrease over-treatment of low-
risk cancer. For this BCC/BDL, we propose to develop multimodal biomarker panels and associated in vitro
diagnostic multivariate index assays (IVDMIAs) for two specific clinical intended uses to improve the
effectiveness of AS: 1) IVDMIAs using serum, urine, and biopsy tissue biomarkers to identify patients with low-
risk PCa from those with aggressive disease, and/or to provide accurate clinical grading and staging to assist in
AS enrollment; and 2) IVDMIAs of non-invasive (serum and urine) biomarkers to sensitively detect early signs of
disease reclassification with clinically meaningful lead time for definitive treatment. To develop these biomarker
panels, we propose four specific aims. Aim 1. To perform integrated proteomic and glycoproteomic
characterization of multimodal clinical specimens to discover and develop biomarkers de novo as well as
integrate biomarkers existing or from our current BDL/BRL for the two specific intended uses; Aim 2. To work
with the BRL component of our BCC to develop high-quality assays for accurate and efficient evaluation of
selected candidate biomarkers; Aim 3. (co-Aim with BRL) To develop and evaluate IVDMIAs to achieve clinically
meaningful performance characteristics for the predefined clinical uses; and Aim 4. To participate in EDRN
network research projects, including actively participating in and contributing to on-going and future network
projects, collaborate with other BCCs and CVCs, and work with EDRN leadership, Executive Committee, and
Data Management and Coordinating Center (DMCC) regarding research direction, data and results report
criteria/standards, and general effort coordination. Innovations of the BDL include unique targeted AS population,
state-of-the-art proteomic and glycoproteomic technologies for both biomarker discovery and pre-validation
phases, immunoassays for the detection of specific modified protein forms, quantitative analysis of tissue
proteins by single-cell analysis and immunohistochemistry staining as well as quantitative measurement using
liquid tissue measurement. Innovative bioinformatics approaches include tools that incorporate existing clinical
and biological knowledge of the disease into the quantitative analysis for discovery and IVDMIA model
optimization and corroborative analysis of the PCa proteome through single-cell analysis and bulk expression
data deconvolution. In summary, the proposed BCC/BDL has assembled a unique collection of well
characterized multimodal biospecimen collections representative of the intended targeted populations; and
proposed a clear path using state-of-the-art and innovative proteomics, glycoproteomics, statistics, and
bioinformatics approaches for biomarker discovery and validation of IVDMIAs to achieve clinically mea...

## Key facts

- **NIH application ID:** 10890725
- **Project number:** 5U2CCA271895-02
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** Hui Zhang
- **Activity code:** U2C (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $334,030
- **Award type:** 5
- **Project period:** 2023-07-20 → 2028-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10890725

## Citation

> US National Institutes of Health, RePORTER application 10890725, Biomarker Development Laboratory (5U2CCA271895-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10890725. Licensed CC0.

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