# Biomarker Reference Laboratory

> **NIH NIH U2C** · JOHNS HOPKINS UNIVERSITY · 2022 · $164,043

## Abstract

Project Summary (BRL)
Centered around the overall goal of the BCC, the proposed BRL assembled a multi-disciplinary team led by Dr.
Daniel W Chan who is the PI of a currently funded EDRN BRL at JHU. The investigators of the BRL are clinical
and basic science researchers, technologists, and quantitative/data scientists who have demonstrated a
successful track record in driving and facilitating the translation of cancer biomarkers into clinical practice. In
addition to summarizing key investigators’ expertise and experience, and institutional structures relevant to the
mission of the BRL, we described in detail how the capabilities of the BRL align with the goals and specific
aims of the proposed BDL to develop and translate biomarkers that are associated with the precursor lesions
and/or early development of high-grade serous ovarian carcinoma (HGSOC). In particular, the BDL and BRL
shared a common aim to develop In vitro diagnostic multivariate index assays (IVDMIAs) to improve the clinical
performance in detecting HGSOC. We provided a detailed description of our “by-design” approach for the
proposed IVDMIA development. It is based on our prior experience of having developed two FDA cleared
IVDIMA tests. The proposed BRL, as a CLIA and CAP certified laboratory and with its close integration the
BDL, will help to streamline the development of biomarkers and accelerate their translation into a clinical
product as IVDMIA for the early detection of HGSOC in high-risk women when the ovarian cancer is still i) at
its precursors (STICs), ii) confinement to the ovary/fallopian tube or iii) low-volume diseases and amenable to
surgical and therapeutic intervention.
We have the following aims:
1. To conduct network collaborative studies with other EDRN CVCs, BCCs, and the DMCC and to serve as a
 resource center for the EDRN network.
2. To provide support to the proposed BCC’s BDL in areas of research assay development and phased
 optimization for conversion to high-quality multiplex targeted assays.
3. To develop high-quality (diagnostic) assays for verified high-priority biomarkers.
4. (co-aim with BDL) To develop in vitro diagnostic multivariate index assays (IVDMIAs)
The currently funded BRL has been a part of EDRN for 15 years. Our numerous accomplishments in
supporting EDRN network studies and collaborative project demonstrated the essential roles we have played
within EDRN and our willingness to serve. This proposed BRL will continue and improve upon this tradition.
.

## Key facts

- **NIH application ID:** 10486411
- **Project number:** 1U2CCA271891-01
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** DANIEL Wanyui CHAN
- **Activity code:** U2C (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $164,043
- **Award type:** 1
- **Project period:** 2022-08-01 → 2027-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10486411

## Citation

> US National Institutes of Health, RePORTER application 10486411, Biomarker Reference Laboratory (1U2CCA271891-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10486411. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*