# Biomarker Reference Laboratory

> **NIH NIH U2C** · JOHNS HOPKINS UNIVERSITY · 2024 · $247,738

## Abstract

Our proposed EDRN BRL, which is located within the Clinical Chemistry Division (CCD) of the Johns Hopkins
Medical Institutions, will be an integral part of the BCC. The BRL will continue to serve as a network resource for
clinical and laboratory validation of biomarkers, which includes technological development and assay refinement,
as well as knowledge of quality management and regulatory requirements. Our laboratory is certified by CAP
and regulated by CLIA (certificates provided). We follow stringent GLP guidelines for quality control and quality
assurance. The proposed product developmental project of the BCC will be conducted at the JHU Center for
Biomarker Discovery and Translation (CBDT). The project goal is to validate prostate cancer biomarkers
discovered by our BDL & BRL during the current funding period, de novo discoveries from the BDL component
of the new BCC, and/or other potential biomarkers from within and outside EDRN using cutting edge technologies
in proteomics, bioinformatics, and clinical assay development. The proposed diagnostic products are in vitro
diagnostic multivariate index assays (IVDMIAs) consisting of a panel of biomarkers 1) to assist in the
preoperative assessment of PCa aggressiveness and decision for enrollment into active surveillance (AS); and
2) non-invasive biomarkers for the detection of rising risk of progression during AS to triage patients for additional
workup procedures for possible disease reclassification. We have assembled a strong team of research and
clinical scientists with many years of experience with cancer biomarkers and in technology development, study
design, bioinformatics, validation, and translation. Dr. Chan, the contact PI and the BRL PI, is the Director of
both CCD and CBDT. He has >30 years of experience in clinical chemistry and has conducted many (>75)
research studies funded by industry on cancer diagnostics leading to FDA approval for clinical use. Furthermore,
several leading scientists from the diagnostics industry will serve as collaborators to provide expertise and
facilitate product development and validation. Our BRL has been extremely productive. Since the inception of
the EDRN in 2000, eight EDRN developed assays have been approved by the FDA for clinical use and of these
eight, our BRL led the development of the OVA1 and Overa serum IVDMIAs for ovarian cancer, led the serum
proPSA validation study, and served as the reference lab for the urine PCA3 validation trial. In addition, Dr. Chan
was involved in the development of the MiCheck Prostate cancer test by Minomic International Ltd. This test was
licensed to a CLIA certified lab. In this application, we plan to continue our commitment to the EDRN mission
through network collaborations with BCCs, CVCs, and the DMCC. With this multi-disciplinary team of scientists
and clinicians, the BRL at JHU offers the best opportunity for the success of cancer biomarker validation and
translation. If the over-treatment, under-treatme...

## Key facts

- **NIH application ID:** 10890730
- **Project number:** 5U2CCA271895-02
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** DANIEL Wanyui CHAN
- **Activity code:** U2C (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $247,738
- **Award type:** 5
- **Project period:** 2023-07-20 → 2028-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10890730

## Citation

> US National Institutes of Health, RePORTER application 10890730, Biomarker Reference Laboratory (5U2CCA271895-02). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10890730. Licensed CC0.

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